Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

GBB · Predicate Candidate Screening

8 FDA 510(k) clearances under this product code; the 50 most recent screened below.

38 daysmedian FDA review time

154 days90th percentile

8clearances measured

K-number	Device	Applicant	Decided	Review days
K964102	TENET TIBIAL FRACTURE SUPPORT	Tenet Medical Engineering	1996-12-05	55
K893598	HYDRAULIC FOOT OPERATED STOOL	Arthro-Medic, Inc.	1989-10-10	154
K831325	NUTROMAT	Medlog GmbH Marketing Services	1983-06-02	38
K831385	LITHOTOMY CHAIR #415	Midmark Corp.	1983-06-02	35
K822264	NAGASHIMA SN OPERATOR'S CHAIR	Kelleher Corp.	1982-10-13	76
K822251	EXAMINATION & TREATMENT CHAIRS	Kelleher Corp.	1982-08-27	29
K822013	NAGASHIMA SN AUTOMATIC TREATMENT CHAIR	Kelleher Corp.	1982-07-28	20
K820636	STORZ #6500 POWER EXAMINATION CHAIR	Storz Instrument Co.	1982-03-26	18

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda