Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

KZJ — Predicate Candidate Screening

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

23 daysmedian FDA review time

68 days90th percentile

18clearances measured

K-number	Device	Applicant	Decided	Review days
K881502	BREWER GEL FOR CAMPYLOBACTER	Fairleigh Dickinson Laboratories, Inc.	1988-04-27	16
K875362	BREWER GEL FOR ANAEROBES	Fairleigh Dickinson Laboratories, Inc.	1988-01-27	27
K872782	BBL(R) GASPAK CO2 POUCH(TM)	Bd Becton Dickinson Vacutainer Systems Preanalytic	1987-08-06	23
K871709	ANAEROBIC TRANSPORT POUCH (CATALYST-FREE)	Difco Laboratories, Inc.	1987-05-15	14
K871238	ANABAG	Scott Laboratories, Inc.	1987-04-03	7
K862123	BIOSPHERE ANAEROBIC ENVIRONMENTAL DEVICE	Marion Laboratories, Inc.	1986-06-16	13
K853534	BBL CAMPY POUCH	Bd Becton Dickinson Vacutainer Systems Preanalytic	1985-08-29	6
K845008	BIO-BAG ENVIRONMENTAL CHAMBER -TYPE A-MULTI-PLATE	Marion Laboratories, Inc.	1985-03-05	69
K844571	CAMPYPAK PLUS W/PALLADIUM CATALYST DISPOS. HYDROGE	Bd Becton Dickinson Vacutainer Systems Preanalytic	1985-01-30	68
K841117	GASPAK PLUS DISPOS. HYDROGEN &	Bd Becton Dickinson Vacutainer Systems Preanalytic	1984-04-04	20
K832229	BBL ANAGEL POWDER	Bd Becton Dickinson Vacutainer Systems Preanalytic	1983-08-12	32
K820308	ANA-DISC SYSTEM	Flow Laboratories, Inc.	1982-03-04	28
K820010	GAS GENERATING KIT, CO2	Oxoid U.S.A., Inc.	1982-01-28	23
K811957	CAMPYPAK	Bd Becton Dickinson Vacutainer Systems Preanalytic	1981-07-23	14
K802494	GAS GENERATING KIT SYSTEM FOR CAMPYLOB.	Oxoid U.S.A., Inc.	1980-11-12	33
K800899	LAB-TEK ANACULT ANAEROBIC CULTURE CHAMBE	Miles Laboratories, Inc.	1980-05-23	35
K800796	GAS PAK II DIS. GENERATOR ENVELOPES	Bd Becton Dickinson Vacutainer Systems Preanalytic	1980-04-24	15
K800539	DISP. HYDROGEN & CO2 GENERATOR ENVELOPE	Bd Becton Dickinson Vacutainer Systems Preanalytic	1980-04-08	29

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