510(k) statement or 510(k) summary ?

#1
Hi All,

Can anyone tell me, why some medical devices have the detailed 510(k) summary in the 510(k) search database, but some only have the brief 510(k) statement?

Here are the examples:

1. K153283, VivoSight Dx Topical OCT System, only has the brief 510(k) statement in the database, but

2. K160878, OPTIS Metallic Stent Optimization E.4 SW, has the detailed 510(k) summary in the database,

even though these two devices have the same Regulation Number (892.1560).

Thanks.
 
Elsmar Forum Sponsor

bio_subbu

Super Moderator
#2
Hi All,

Can anyone tell me, why some medical devices have the detailed 510(k) summary in the 510(k) search database, but some only have the brief 510(k) statement?

Here are the examples:

1. K153283, VivoSight Dx Topical OCT System, only has the brief 510(k) statement in the database, but

2. K160878, OPTIS Metallic Stent Optimization E.4 SW, has the detailed 510(k) summary in the database,

even though these two devices have the same Regulation Number (892.1560).

Thanks.
It's a manufacturer choice to choose either to submit a 510(k) summary or a statement. If manufacturer submitted a 510(k) statement, the detailed 510(k) won't be available in the database, but its 510(k) owners responsibility to provide safety and effectiveness information supporting the FDA finding of substantial equivalence to ANY person within 30 days of a written request. you can contact the company directly, and you will get the redacted copies of 510(k) (with patient identifiers, trade secret and confidential information deleted).

See the link on Content of a 510(k), Content of a 510(k) and refer particularly Sec. 807.93 Content and format of a 510(k) statement, Or you can request 510k through the FDA FOIA (Freedom of Information Act).
 
Last edited:
#3
Thank you bio_subbu!

I have read the "Content of a 510(k)" before, but I didn't notice that the company has to provide the information to "ANY" person.

I will try to ask for some 510(k) information.

Thanks again!
 
Thread starter Similar threads Forum Replies Date
R 510(k) Statement Requests to a Company 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 15
V Old 510(k) with no Indication Statement 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
E Financial certification or disclosure statement for applying 510(k) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 9
R FDA 510(k) Summary and FDA 510(k) Statement 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 10
M FDA 510(k) Summary and FDA 510(k) Statement Differences 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
E Mergers & Acquisitions tips: Is an acquisition likely after 510(k) clearance? Other Medical Device and Orthopedic Related Topics 5
F Can this device without tolerances be used as a predicate for our 510(k)? US Food and Drug Administration (FDA) 4
T FDA level of concern vs IEC 62304 safety classification - 510(k) exempt device Other US Medical Device Regulations 13
F Using non-randomized clinical study for change in existing 510(k) device? US Food and Drug Administration (FDA) 1
A A strange question about predicate device selected in 510(k) submission Medical Device and FDA Regulations and Standards News 8
B Recent 510(k) Clearances for Devices Imported from China Medical Device and FDA Regulations and Standards News 1
S Traditional or Special 510(k) US Food and Drug Administration (FDA) 7
S New 510(K) US Food and Drug Administration (FDA) 2
marmotte Help with Surgical Class I + 510(k) exemption US Food and Drug Administration (FDA) 0
M ESTAR 510(k) submission question Medical Device and FDA Regulations and Standards News 0
K 510(k) Manufacturer question (private label and manufacture under another persons 510(k)) US Food and Drug Administration (FDA) 1
Ed Panek ANNUAL FDA Registration - What 510(k) number to use? US Food and Drug Administration (FDA) 1
L How to find a good 510(k) submission training? Other US Medical Device Regulations 2
shimonv Where do you place Human Factors report in a 510(k) application? Other US Medical Device Regulations 3
S FDA 510(K) submission question US Food and Drug Administration (FDA) 4
Watchcat REGULATORY WATCHCAT - The 510(k) Submissions Tracker Other US Medical Device Regulations 0
S Product Code 510(k) exemption US Food and Drug Administration (FDA) 1
V 510 k submission RTA (Acceptance Checklist ) Other US Medical Device Regulations 8
Watchcat 510(k)s and "Innovation"? Other US Medical Device Regulations 2
D Change to labelling - does it require a new 510(k)? US Food and Drug Administration (FDA) 5
A How can we change a device trade name in 510(k) summary? US Food and Drug Administration (FDA) 0
K PMA vs 510(k) for Mammography Machine US Food and Drug Administration (FDA) 2
S Predicate Material 510(k) US Food and Drug Administration (FDA) 1
S Predicate Material 510(k) Medical Device and FDA Regulations and Standards News 3
J US Device Listing when not the 510(k) owner Medical Device and FDA Regulations and Standards News 2
supadrai Possible to Submit a 510(k) if you have never, do not and cannot produce the device for which you're submitting the application? US Food and Drug Administration (FDA) 4
S Special 510(k) for orthopedic implant 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
M Label change - 510(k) Medical Device and FDA Regulations and Standards News 5
G We want to add Covid-2 /19 to our air filter 510 K Medical Device and FDA Regulations and Standards News 0
A The refund of 510(k) user fee Medical Device and FDA Regulations and Standards News 0
A Which guidance do you use for guiding the requirements of IFU for 510(k) submission? Medical Device and FDA Regulations and Standards News 5
A 510(k) review timeline 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
L Impact on 510(k) to use an additional manufacture US Food and Drug Administration (FDA) 0
T 510(k) submission - Which name should I use in the submission? Other US Medical Device Regulations 3
Watchcat Advantages to pursuing a Special 510(k) instead of a Traditional 510(k) Other US Medical Device Regulations 5
A 510(k) registration and listing US Food and Drug Administration (FDA) 1
Aymaneh Traditional 510(k) Declaration of Conformity Other Medical Device Regulations World-Wide 3
M Should 510(k) Predicates be Actively Listed Devices? Other US Medical Device Regulations 12
A Several sections of traditional 510(K) have the same or similar requirement of content. US Food and Drug Administration (FDA) 4
A Some questions about voluntary consensus standards in traditional 510(k) submission US Food and Drug Administration (FDA) 6
A Some doubts about traditional 510(k) submission US Food and Drug Administration (FDA) 5
A Bench test report translation to English for 510(k) submission Other US Medical Device Regulations 2
S Special 510(K) - Labeling change from Rx to OTC Other US Medical Device Regulations 11
J 510(k) for a control kit for an external IVD test kit 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
Y Expanding the indications for use for a 510(k) cleared device Medical Device and FDA Regulations and Standards News 4

Similar threads

Top Bottom