Atlas FDA

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

KJA — Predicate Candidate Screening

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

26 daysmedian FDA review time
69 days90th percentile
13clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K972404VACUTAINER BRAND SAFETY BLOOD COLLECTION ASSEMBLY(MULTIPLE)Bd Becton Dickinson Vacutainer Systems Preanalytic1997-07-22260
K933228KAPTON PEEL POUCHAmerican Fluoroseal Corp.1994-03-302710
K885121CELL SCRAPERBd Becton Dickinson Vacutainer Systems Preanalytic1988-12-28160
K873890TISSUE CULTURE FLASKSNunc, Inc.1987-11-25630
K873889TISSUE CULTURE TUBESNunc, Inc.1987-11-25630
K871324DU PONT STERICELL CELL CULTURE SYSTEME.I. Dupont DE Nemours & Co., Inc.1987-04-14110
K870865TISSUE CULTURE BAGAmerican Fluoroseal Corp.1987-03-30270
K864021TISSUE CULTURE FLASKFenwal Laboratories1986-10-29140
K862152TISSUE CULTURE FLASK PL 732 PLASTIC ACCESSORY PRODTravenol Laboratories, S.A.1986-06-16130
K861253TISSUE CULTURE FLASK PL 732 PLASTICTravenol Laboratories, S.A.1986-04-1180
K853441FETAL BOVINE SERUM IN TRANSFER CONTAINERNewport Biosystems, Inc.1985-08-26130
K852532NEWPORT MEDIA TRANSFER CONTAINERNewport Bio Systems1985-08-22690
K823138CELL SCRAPERCorning Costar Corp.1982-11-29350

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