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

KSG — Predicate Candidate Screening

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

29 daysmedian FDA review time

44 days90th percentile

13clearances measured

K-number	Device	Applicant	Decided	Review days
K812565	ELUTION SOLUTION	Biological Corp. of America	1981-10-23	44
K812222	EM-X	Biological Corp. of America	1981-09-23	47
K800943	PENTEX BOVINE ALBUMIN 30% SOLUTION	Miles Laboratories, Inc.	1980-05-08	16
K800189	BOVINE ALBUMIN 22% & 30% SOLUTIONS	Gotham Biologics, Inc.	1980-02-13	15
K791791	ORTHO ANTIBODY ENHANCEMENT SOLUTION	Ortho Diagnostics, Inc.	1979-10-11	30
K791113	LOW IONIC STRENGTH SOLUTION (LISS)	Hyland Therapeutic Div., Travenol Laboratories	1979-06-28	13
K790973	LO-ION	Gamma Biologicals, Inc.	1979-06-15	23
K790776	DADE LOW IONIC STRENGTH SOLUITION (LISS)	Dade, Baxter Travenol Diagnostics, Inc.	1979-05-23	33
K790498	LISS REAGENT	Fisher Scientific Co., LLC	1979-04-03	21
K781435	ORTHO LOW IONIC SOLUTION	Ortho Diagnostics, Inc.	1978-09-14	29
K781397	EM-V	Biological Corp. of America	1978-09-14	34
K780413	LOW IIONIC STRENGTH SOLUTION	Pfizer, Inc.	1978-04-24	40
K780556	SPECT RIM (LISS)	Bd Becton Dickinson Vacutainer Systems Preanalytic	1978-04-24	19

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