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

Concord/Portex — Predicate Candidate Screening

23 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

86 daysmedian FDA review time

304 days90th percentile

23clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K923559	STERI-CATH MDI	Concord/Portex	1993-10-25	465	0
K930218	SUBCUTANEOUS TUNNELING NEEDLE AND HANDLES	Concord/Portex	1993-07-27	193	0
K924541	EPIDURAL MINIPACK	Concord/Portex	1993-07-09	304	0
K930286	DRI-VENDT/PROVENT/ACCUVENT ARTERIAL BLOOD GAS KITS	Concord/Portex	1993-06-22	152	0
K923127	NEEDLE-PRO CARTRIDGE	Concord/Portex	1993-04-29	307	0
K923910	HEAT MOISTURE CONDENSER	Concord/Portex	1993-01-26	175	0
K922749	LOW PROFILE TRACHEOSTOMY TUBE	Concord/Portex	1992-09-02	86	3
K922445	VACU-PRO	Concord/Portex	1992-08-12	82	0
K915452	ANESTHESIA BREATHING CIRCUIT	Concord/Portex	1992-02-14	71	0
K911809	NEW-VENT	Concord/Portex	1991-08-26	125	0
K912124	TRACHEOSTOMY TUBE AND CUFF	Concord/Portex	1991-08-16	95	0
K912043	ACCU-VENT(TM) WITH NEEDLE-PRO(TM)	Concord/Portex	1991-07-05	58	0
K911638	SYRINGE TIP CAP	Concord/Portex	1991-06-21	71	0
K911037	SAFETY NEEDLE SHEATH, MODIFICATION	Concord/Portex	1991-05-03	63	0
K905011	ORAL PHARYNGEAL CLEANSING DEVICE	Concord/Portex	1991-01-31	85	0
K904198	SAFETY NEEDLE SHEATH	Concord/Portex	1990-12-19	98	0
K903730	D.I.C. TRACHEOSTOMY TUBES & LARYNGECTOMY TUBES	Concord/Portex	1990-09-25	40	0
K902687	STERI-CATH-DL	Concord/Portex	1990-08-29	71	0
K902116	MODIFIED ENDOBRONCHIAL TUBE	Concord/Portex	1990-08-03	85	0
K902383	STERI-CATH(TM)	Concord/Portex	1990-07-12	43	0
K896031	AMNIOTIC FLUID SAMPLER (AMNIOCENTESIS TRAY)	Concord/Portex	1990-01-12	88	0
K891316	ANESTHESIA/RESPIRATORY DISPOSABLE MASK	Concord/Portex	1989-08-21	161	0
K892343	SUCTION CONTROL VALVE	Concord/Portex	1989-04-24	19	0

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