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

Cybex — Predicate Candidate Screening

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

98 daysmedian FDA review time

736 days90th percentile

9clearances measured

K-number	Device	Applicant	Decided	Review days
K950095	CYBEX 770	Cybex	1995-06-21	162
K905525	CYBEX 6000	Cybex	1991-02-14	66
K881681	CYBEX BACK TESTING AND REHABILITATION SYSTEM	Cybex	1990-04-25	736
K881676	LINEAR LIFT DEVICE	Cybex	1990-04-25	736
K894154	METABOLIC SYSTEMS	Cybex	1989-10-24	132
K873599	EDI 320	Cybex	1987-10-16	42
K872911	CYBEX 340	Cybex	1987-09-24	62
K844368	LINEAR LIFT DEVICE	Cybex	1985-02-19	98
K843739	CYBEX TORSO TESTING & REHABILITATION	Cybex	1984-11-29	65

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