Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

F. & F. Koenigkramer — Predicate Candidate Screening

9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

38 daysmedian FDA review time

71 days90th percentile

9clearances measured

K-number	Device	Applicant	Decided	Review days
K860519	RELIANCE MODEL 200 PODIATRY CHAIR	F. & F. Koenigkramer	1986-02-19	8
K853149	RELIANCE 1000, RELIANCE 1500, RELIANCE 2000	F. & F. Koenigkramer	1985-09-05	38
K853150	RELIANCE 6100	F. & F. Koenigkramer	1985-09-05	38
K853151	RELIANCE 5000	F. & F. Koenigkramer	1985-09-05	38
K843046	RELIANCE TREATMENT CABINET	F. & F. Koenigkramer	1984-09-27	56
K834060	RELIANCE OPHTHALMIC SLIT LAMP R-083	F. & F. Koenigkramer	1984-02-04	71
K831568	RELIANCE TEMPO OPHTH. INSTR STAND	F. & F. Koenigkramer	1983-06-30	45
K812544	RELIANCE OPHTHALMIC INSTRUMENT CONTROL	F. & F. Koenigkramer	1981-09-21	17
K761147	RELIANCE MOD-U-LINE M-700	F. & F. Koenigkramer	1977-01-28	63

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