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

KSQ · Predicate Candidate Screening

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

51 daysmedian FDA review time

67 days90th percentile

8clearances measured

K-number	Device	Applicant	Decided	Review days
K842746	HYCEL ROTOR-MIXER AND/OR MULTI	R&D Systems, Inc.	1984-08-17	35
K820712	SEPCOR UNIT COLLECTION MONITOR	Separation Science Corp.	1982-05-07	53
K812533	PLATELET AGITATOR	Helmer Labs, Inc.	1981-09-29	27
K810617	MOBILE MATIC AUTOMATIC DONOR SCALE	Lifeline Instruments, Inc.	1981-04-07	29
K802608	HEMATIC BLOOD MIXER	Helmer Labs, Inc.	1980-12-11	51
K800104	ROYCO MODEL 951 CELL MIXER	Royco Instruments	1980-02-06	21
K780189	PLATELET ROTATOR	Travenol Laboratories, S.A.	1978-03-30	52
K760743	DONORMATIC (BLOOD COLLECTION DEVICE)	Lifeline Instruments, Inc.	1976-12-06	67

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