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

KSF — Predicate Candidate Screening

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

36 daysmedian FDA review time

97 days90th percentile

12clearances measured

K-number	Device	Applicant	Decided	Review days
K811713	AVI-D CONTROL	Ortho Diagnostic Systems, Inc.	1981-10-23	128
K810599	DADE RH CONTROL REAGENT	American Dade	1981-03-31	25
K801425	RH CONTROL	North American Biologicals, Inc.	1980-07-14	27
K800658	RST-SERIES CONTROL	Gamma Biologicals, Inc.	1980-04-16	21
K800310	ORTHO ANTISERA CONTROL	Ortho Diagnostics, Inc.	1980-03-05	22
K800239	RH-HR NEGATIVE CONTROL REAGENT	Gotham Biologics, Inc.	1980-02-21	16
K790249	TEST CELLS	Hyland Therapeutic Div., Travenol Laboratories	1979-05-16	97
K790025	COUNTER CHECK, H001, H002, H003	Diagnostic Technology, Inc.	1979-01-17	14
K780665	RECAP	Bca Biological Corp. of America	1978-06-06	46
K780097	QUALITY CONTROL SYSTEM, SPECTRA	Bd Becton Dickinson Vacutainer Systems Preanalytic	1978-04-24	95
K771814	REAGENT CONFIDENCE SERA	Ortho Diagnostics, Inc.	1977-11-07	41
K761284	UNIVAL CONTROL CELLS	Dade, Baxter Travenol Diagnostics, Inc.	1977-01-25	36

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