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

Shiley, Inc. — Predicate Candidate Screening

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

60 daysmedian FDA review time

128 days90th percentile

174clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K920594	SHILEY PERFUSION TUBING SETS	Shiley, Inc.	1993-03-18	401	0
K910991	SHILEY THERAPEUTIC AUTOTRANSFUSION SYSTEM	Shiley, Inc.	1991-11-27	265	0
K911876	SHILEY PLEXUS(R) VENOUS RESERVOIR, PVR1200	Shiley, Inc.	1991-08-09	102	0
K910923	BCD ADVANCED	Shiley, Inc.	1991-04-09	35	0
K901548	BIOMEDICAL SENSORS-SHILEY BGM 4000 INTRA BLOOD GAS	Shiley, Inc.	1991-01-14	286	0
K903435	SHILEY SPECIALIZED TRACHEOSTOMY TUBE	Shiley, Inc.	1990-10-02	63	19
K901624	SHILEY PLEXUS INTEGRAL RESERVOIR HOLLOW FIBER OXY.	Shiley, Inc.	1990-07-03	85	0
K901250	PLEXUS 2(TM) INFANT HOLLOW FIBER OXYGENATOR	Shiley, Inc.	1990-06-11	87	0
K901249	PLEXUS 3.5(TM) PEDIATRIC HOLLOW FIBER OXYGENATOR	Shiley, Inc.	1990-06-11	87	0
K900797	STOCKERT SHILEY DUAL PRESSURE CONTROL MODULE XR	Shiley, Inc.	1990-05-10	79	0
K900548	SHILEY PHONATION VALVE	Shiley, Inc.	1990-04-23	77	0
K900186	BONCHEK-SHILEY CARDIAC JACKET W/RECIRCULATION SET	Shiley, Inc.	1990-04-10	84	0
K900753	SHILEY VEIN IRRIGATION CANNULA (BEVELED & BLUNT)	Shiley, Inc.	1990-04-10	53	0
K900339	HAND-HELD INTRACARDIAC SUCKERS W/ERGONOMIC HANDLES	Shiley, Inc.	1990-03-28	64	0
K894784	MODIFIED SHILEY FEMORAL VENOUS CANNULA	Shiley, Inc.	1990-03-28	247	0
K893711	DIDECO-SHILEY AUTOTRANSFUSION CARDIOTOMY RESERVOIR	Shiley, Inc.	1990-02-28	286	0
K895149	NEOCATH 1000 UMBILICAL ARTERY OXYGEN MONITORING SY	Shiley, Inc.	1989-11-28	97	0
K895150	CONTINUCATH 1000 INTRAVASCULAR OXYGEN MONITORING	Shiley, Inc.	1989-11-28	97	0
K895388	SHILEY ELBOW 15MM SWIVEL CONNECTOR	Shiley, Inc.	1989-10-27	58	0
K894630	SHILEY PLEXUS(TM) ADULT HOLLOW FIBER OXYGENATOR	Shiley, Inc.	1989-10-20	88	0
K894668	MODIFIED SHILEY THERAPEUTIC AUTOTRANSFUSION SYSTEM	Shiley, Inc.	1989-10-20	87	0
K894681	REVISED LABELING FOR ARTERIAL EMBOLECTOMY CATHETER	Shiley, Inc.	1989-10-12	79	0
K894294	DIDECO-SHILEY UNIVERSAL Y	Shiley, Inc.	1989-08-15	53	0
K890194	SHILEY SPECIALIZED TRACHEOSTOMY TUBE	Shiley, Inc.	1989-07-20	184	0
K892446	SHILEY EQUIPMENT SUPPORT CARTS ESC-002 & ESCB-02	Shiley, Inc.	1989-07-14	95	0
K884564	SHILEY THERAPEUTIC AUTOTRANSFUSION SYSTEM-PROGRAMM	Shiley, Inc.	1989-05-05	185	0
K890980	MODIFIED STOCKERT-SHILEY VENOUS CATHETER	Shiley, Inc.	1989-05-01	63	0
K890904	MODIFIED STOCKERT-SHILEY CAPS MULTI. ROLLER PUMP	Shiley, Inc.	1989-04-12	61	0
K884872	DIDECO-SHILEY AUTOTRANSFUSION CARDIOTOMY RESERVOIR	Shiley, Inc.	1989-01-30	70	0
K884730	SHILEY PERC TRACHEOSTOMY SYSTEM	Shiley, Inc.	1989-01-17	68	0
K884393	MODIFIED SHILEY FEMORAL ARTERIAL CANNULA	Shiley, Inc.	1988-12-27	77	0
K883330	BASIC HEATER-COOLER UNIT, 115/100V 16-02-20	Shiley, Inc.	1988-09-26	49	0
K883331	BASIC HEATER-COOLER UNIT W/MAST, 115/110V 16-21-10	Shiley, Inc.	1988-09-26	49	0
K883332	MAST FOR BASIC HEATER-COOLER UNIT 16-09-00	Shiley, Inc.	1988-09-26	49	0
K881692	DIDECO-SHILEY FLUID COLLECTION BAG	Shiley, Inc.	1988-07-08	80	0
K881733	SHILEY FEMORAL CORONARY PERFUSION CATHETER	Shiley, Inc.	1988-07-06	75	0
K881691	PREASSEMBLED SURGICAL WASH SET 122,175,225,375AA	Shiley, Inc.	1988-07-05	77	0
K881734	SHILEY FEMORAL LEFT VENTRICULAR VENT CATHETER	Shiley, Inc.	1988-07-05	74	0
K881683	DIDECO-SHILEY AUTOTRANS BT 795/AA	Shiley, Inc.	1988-06-27	69	0
K881073	SHILEY FEMORAL CANNULAE INTRODUCER KIT	Shiley, Inc.	1988-06-09	87	0
K881074	SHILEY FEMORAL VENOUS CANNULA	Shiley, Inc.	1988-05-31	78	0
K881072	SHILEY FEMORAL ARTERIAL CANNULA	Shiley, Inc.	1988-05-31	78	0
K881006	STOCKERT-SHILEY BUBBLE MONITOR 23-23-01	Shiley, Inc.	1988-05-24	76	0
K880663	SHILEY BCD PLUS HEAT EXCHANGER	Shiley, Inc.	1988-05-11	83	0
K881421	DIDECO-SHILEY FEED TUBE SUPPORT ARMS AND HOOK	Shiley, Inc.	1988-05-04	30	0
K881290	MODIFIED SHILEY DUAL LUMEN SUBCLAVIAN CANNULA	Shiley, Inc.	1988-04-27	30	0
K880614	SHILEY DISP. CANNULA CUFFLESS TRACEOSTOMY TUBE	Shiley, Inc.	1988-03-09	22	0
K880247	MODIFIED SHILEY LOW PRESSURE CUFFED TRACHEO. TUBES	Shiley, Inc.	1988-02-12	23	0
K872719	EXPANDED USE OF HARDSHELL VENOUS RESERV. W/FILTER	Shiley, Inc.	1987-09-30	82	0
K872721	EXPANDED USE FOR SHILEY 3L CARDIOTOMY RESERVOIR	Shiley, Inc.	1987-09-23	75	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