Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

Mallinckrodt Medical · Predicate Candidate Screening

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

85 daysmedian FDA review time

263 days90th percentile

43clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K082520	SEALGUARD EVAC ENDOTRACHEAL AND ENDOTRACHEAL TUBES	Mallinckrodt Medical	2008-10-02	30	0
K051416	SHILEY TRACHEOSOFT XLT EXTENDED LENGTH TRACHEOSTOMY TUBE AND	Mallinckrodt Medical	2005-06-16	15	0
K972258	HI-CARE CLOSED SUCTION SYSTEM	Mallinckrodt Medical	1997-12-29	195	0
K971267	SHILEY EXTENDED LENGTH, DISPOSABLE CANNULA, TRACHEOSTOMY TUB	Mallinckrodt Medical	1997-09-25	174	0
K963732	PERCUTANEOUS DUAL CANNULA TRACHEOSTOMY TUBE WITH LOW PRESSUR	Mallinckrodt Medical	1997-06-26	282	2
K955721	CUFFED OROPHARYNGEAL AIRWAY (COPA)	Mallinckrodt Medical	1997-03-28	466	0
K965132	HI-LO EVAC AND EVAC II ENDOTRACHEAL TUBES	Mallinckrodt Medical	1997-03-20	87	0
K962045	ANESTHESIA BREATHING CIRCUIT/ANESTHESIA BREATHING KIT	Mallinckrodt Medical	1996-11-26	182	0
K962173	SHIKEY TRACHEOSTOMY TUBES AND ACCESSORIES	Mallinckrodt Medical	1996-10-04	121	23
K955680	SHILEY CUFFED PEDIATRIC TRACHEOSTOMY TUBE; LONG CUFFED	Mallinckrodt Medical	1996-03-13	90	8
K954749	MALLINCKRODT SHILEY 15MM CAP	Mallinckrodt Medical	1996-01-24	100	0
K954146	UTK-DTE AUTILARY SHIELD	Mallinckrodt Medical	1995-12-06	92	0
K953400	GUEDEL AIRWAY	Mallinckrodt Medical	1995-10-24	96	0
K953295	ANESTHESIA FACE MASK	Mallinckrodt Medical	1995-08-11	28	0
K952036	FLEXLIFE	Mallinckrodt Medical	1995-06-08	38	0
K945513	MALLINCKRODT SHILEY NEONATAL, PEDIATRIC, LONG PEDIATRIC TRAC	Mallinckrodt Medical	1995-01-13	65	1
K943739	SOFTOUCH DIAGNOSTIC INTRAVASCULAR CATHETER	Mallinckrodt Medical	1994-11-15	105	4
K943276	WARMTOUCH PLASTIC WARMING COVER	Mallinckrodt Medical	1994-09-19	74	0
K944124	SPIROBAC ADAPTERS	Mallinckrodt Medical	1994-09-08	16	0
K942392	AIRWAY CONNECTOR WITH FLEX TUBE	Mallinckrodt Medical	1994-08-22	95	0
K942794	HYGROLIFE	Mallinckrodt Medical	1994-08-22	69	0
K941676	STERIVENT AND STERIVENT S	Mallinckrodt Medical	1994-05-20	45	1
K941536	BARRIERBAC AND BARRIERBAC S	Mallinckrodt Medical	1994-04-19	20	1
K941585	HYGROSTER	Mallinckrodt Medical	1994-04-19	19	0
K941381	HYGROBAC,S HYGROBOY AND HYGROBABY	Mallinckrodt Medical	1994-04-15	24	1
K941535	TRACHEOLIFE	Mallinckrodt Medical	1994-04-15	16	1
K941246	RAE II TRACHEAL TUBE	Mallinckrodt Medical	1994-04-11	27	0
K934685	SOFTTOUCH GUIDE CATHETER	Mallinckrodt Medical	1994-04-07	189	0
K931479	SOFTOUCH DIAGNOSTIC INTRAVASCULAR CATHETER	Mallinckrodt Medical	1993-10-06	196	0
K932280	RAE(R) II TRACHEAL TUBE	Mallinckrodt Medical	1993-07-08	57	0
K923538	MON-A-THERM FOLEY KIT	Mallinckrodt Medical	1993-05-27	315	0
K922946	VAPORTEMP HEAT AND MOISTURE EXCHANGER	Mallinckrodt Medical	1993-03-08	263	0
K914887	ESOPHAGEAL STETHOSCOPE W/TEMP SENSOR/GASTRIC SUCT	Mallinckrodt Medical	1992-05-08	191	0
K912191	SOFTOUCH(R) GUIDING CATHETER W/BUMPER TIP	Mallinckrodt Medical	1991-07-30	74	0
K912199	SOFTTOUCH(R) GUIDING CATHETER	Mallinckrodt Medical	1991-07-30	74	0
K902405	MALLARD MEDICAL MODEL 2400 ANESTHESIA VENTILATOR	Mallinckrodt Medical	1991-03-04	277	0
K905548	PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY GUIDEWIRE	Mallinckrodt Medical	1991-02-25	76	0
K905547	SOFTOUCH GUIDING CATHETER	Mallinckrodt Medical	1991-02-05	56	0
K905773	PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER	Mallinckrodt Medical	1991-01-30	34	0
K902317	PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATH.	Mallinckrodt Medical	1990-12-03	194	0
K904212	HIGH-PRESSURE CONNECTOR TUBE	Mallinckrodt Medical	1990-12-03	82	0
K903330	MALLINCKRODT MEDICAL, INC., INFUSSION CATHERTER	Mallinckrodt Medical	1990-10-23	90	0
K902953	SOFTOUCH GUIDING CATHETER	Mallinckrodt Medical	1990-09-28	85	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