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

Deknatel, Inc. — Predicate Candidate Screening

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

82 daysmedian FDA review time

529 days90th percentile

37clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K963850	PLEUR-EVAC SAHARA PLUS MODEL S-1150 CONTINUOUS REINFUSION AU	Deknatel, Inc.	1997-04-22	209	0
K962683	SNOWDEN-PENCER COMPUTERIZED HIGH FLOW INSUFFLATOR	Deknatel, Inc.	1997-01-10	184	0
K964070	DEKNATEL DSP PLEUR-EVAC AUTOTRANSFUSION BLOOD RECOVERY BAG	Deknatel, Inc.	1996-12-31	82	0
K963098	PLEUR-EVAC SHARA PLUS MODEL S-2150/CONTINUOUS REINFUSION AUT	Deknatel, Inc.	1996-11-08	91	0
K962856	PLEUR-EVAC SAHARA ADULT/PEDIATRIC CHEST DRAINAGE SYSTEM MODE	Deknatel, Inc.	1996-08-28	37	1
K925243	DEKNATEL(TM) PLEUR-EVAC(R) THORACIC CATHETER	Deknatel, Inc.	1994-07-27	649	0
K930739	SUTURES POLYPROP., POLYETHELINE, NYLON & SILK	Deknatel, Inc.	1994-07-26	529	1
K930738	SURGICAL SUTURES, PGL, GUT, DEKLENE, OPTHAMEND ETC	Deknatel, Inc.	1994-07-26	529	9
K930740	SURGICAL SUTURE, NONABSORABLE STAINLESS STEEL	Deknatel, Inc.	1994-07-26	529	1
K926338	PLEUR-EVAC CARDIOTOMY RESERVOIR # CR-9400 & 9400F	Deknatel, Inc.	1994-07-26	585	0
K931106	BIOSURGE(TM) SYNCHRONOUS AUTOTRANS PROCEDURE KIT	Deknatel, Inc.	1993-10-06	217	0
K924337	PLEUR-EVAC(R) ADULT/PEDI DUAL COLL CHEST DRAIN SYS	Deknatel, Inc.	1993-07-28	335	0
K925046	PLEUR-EVAC CARDIOTOMY RESERVOIR	Deknatel, Inc.	1993-04-20	196	0
K911905	DEKNATEL(R) MICROFLEX OPHTHAL POLY SUTURE,MODIFIED	Deknatel, Inc.	1991-07-02	74	0
K910211	ORTH-EVAC(TM) SUCTION HAND BULB MODEL NO. 01-150	Deknatel, Inc.	1991-04-03	78	0
K905768	PLEUR-EVAC CHEST DRAINAGE SYSTEMS	Deknatel, Inc.	1991-02-11	46	0
K903643	DEKNATEL MICROFLEX OPHTHALMIC POLYPROPYLENE SUTURE	Deknatel, Inc.	1990-12-24	136	0
K900325	ORTH-EVAC TM	Deknatel, Inc.	1990-07-03	161	0
K896697	PLEUR-EVAC(R) A-6020--INFANT SINGLE USE CHEST DRAI	Deknatel, Inc.	1990-02-08	72	0
K892915	PLEUR-EVAC A-8002--ADULT/PEDIATRIC DUAL COLLECTION	Deknatel, Inc.	1989-06-21	62	0
K890432	DEKNATEL HIGH PRECISION VASCULAR PUNCH(TM)	Deknatel, Inc.	1989-04-13	76	0
K890129	PLEUR-EVAC(R) A-8020--INFANT CHEST DRAINAGE SYSTEM	Deknatel, Inc.	1989-04-10	88	0
K890431	PLEUR-EVAC(R) A-8000--ADULT/PEDIATRIC CHEST DRAIN	Deknatel, Inc.	1989-04-04	67	0
K884844	PLEUR-EVAC(R) A-7002--ADULT/PEDIATRIC DRAINAGE	Deknatel, Inc.	1989-01-24	64	0
K883082	PLEUR-EVAC(R)-A-7020-INFANT CHEST DRAIN SYSTEM	Deknatel, Inc.	1988-10-13	84	0
K882223	PLEUR-EVAC-A-7000--ADULT/PEDI CHEST DRAINAGE SYST	Deknatel, Inc.	1988-08-16	82	0
K881252	PLEUR-EVAC(R) A6000 ADULT/PEDIATRIC CHEST DRAINAGE	Deknatel, Inc.	1988-06-17	86	0
K880162	PLEUR-EVAC--A-5002 CHEST DRAINAGE SYSTEM W/AUTO	Deknatel, Inc.	1988-03-21	68	0
K873748	RICA(TM)-RING INTEST. COMPRESS. STAPLE ANASTOM KIT	Deknatel, Inc.	1988-01-06	112	0
K873728	DEKNATEL TEMPORARY CARDIAC PACING WIRE	Deknatel, Inc.	1987-11-03	48	0
K873525	DEKNATEL TROCAR CATHETER	Deknatel, Inc.	1987-11-02	62	0
K873517	DEKNATEL THORACIC CATHETER	Deknatel, Inc.	1987-11-02	62	0
K862115	DEKNA BAND KIT	Deknatel, Inc.	1986-08-19	77	0
K862524	DEKNATEL (R) TREPHINE	Deknatel, Inc.	1986-08-11	40	0
K855121	COLOSHIELD KIT	Deknatel, Inc.	1986-01-08	16	0
K854301	PLEUR-EVAC II AUTOTRANSFUSION SYSTEM	Deknatel, Inc.	1985-11-19	25	0
K760248	GLOVES, APARTICULATE SURGICAL	Deknatel, Inc.	1976-08-09	21	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