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

LTW — Predicate Candidate Screening

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

93 daysmedian FDA review time

196 days90th percentile

16clearances measured

K-number	Device	Applicant	Decided	Review days
K852613	MIC-CONCEPT SYSTEM	Microtech Medical Systems, Inc.	1985-09-20	93
K853596	PRECEPT CEFOPERAZONE	Austin Biological Laboratories	1985-09-16	20
K853273	PRECEPT CEFTRIAXONE	Austin Biological Laboratories	1985-09-16	42
K853685	PRECEPT TM CARBENICILLIN	Austin Biological Laboratories	1985-09-16	178
K853772	PRECEPT METHICILLIN	Austin Biological Laboratories	1985-09-16	147
K853689	PRECEPT TM MOXALACTAM	Austin Biological Laboratories	1985-09-13	196
K853686	PRECEPT TM AMIKACIN	Austin Biological Laboratories	1985-09-13	175
K853684	PRECEPT KANAMYCIN	Austin Biological Laboratories	1985-09-13	175
K853687	PRECEPT NETILMICIN 32-13	Austin Biological Laboratories	1985-09-13	196
K853688	PRECEPT TM TOBRAMYCIN	Austin Biological Laboratories	1985-09-13	196
K853053	PRECEPT ERYTHROMYCIN	Austin Biological Laboratories	1985-08-29	41
K853263	PRECEPT AVGMENTIN	Austin Biological Laboratories	1985-08-29	24
K850347	API UNISCEPT KB	Analytical Products, Inc.	1985-03-26	57
K844159	API UNISCEPT MIC 100UL	Analytical Products, Inc.	1984-12-14	51
K844231	SCEPTOR BETA-LACTAM PLUS MIC PANEL	Bd Becton Dickinson Vacutainer Systems Preanalytic	1984-11-07	8
K843733	API UNISCEPT KB	Analytical Products, Inc.	1984-10-24	30

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