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

Mallinckrodt Critical Care · Predicate Candidate Screening

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

36 daysmedian FDA review time

91 days90th percentile

92clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K880343	BURNEY GALLBLADDER CATHETER KIT	Mallinckrodt Critical Care	1989-05-01	461	0
K874605	HI-LO TEMP(R) MYOCARDIAL TEMPERATURE SENSOR	Mallinckrodt Critical Care	1988-02-02	85	0
K874514	HI-LO TEMP(R) GENERAL PURPOSE TEMPERATURE PROBE	Mallinckrodt Critical Care	1988-01-29	88	0
K874568	HI-LO TEMP(R) MODEL 8700 PATIENT TEMP MONITOR	Mallinckrodt Critical Care	1988-01-06	62	0
K874404	HI-LO TEMP(R) SKIN TEMPERATURE SENSOR	Mallinckrodt Critical Care	1987-11-06	9	0
K873461	LASER-FLEX(TM) TRACHEAL TUBE (CUFFED)	Mallinckrodt Critical Care	1987-11-06	70	0
K873833	THERMOCOUPLE ADAPTER	Mallinckrodt Critical Care	1987-11-03	43	0
K873004	GUIDING CATHETER	Mallinckrodt Critical Care	1987-09-15	42	0
K871204	CUFFED TRACHEAL TUBE (MULTIPLE)	Mallinckrodt Critical Care	1987-04-21	27	1
K862666	UNCUFFED LASER RESISTEANT TRACHEAL TUBE(TENTATIVE)	Mallinckrodt Critical Care	1986-08-01	18	0
K862653	LUER LOCK ADAPTER/NUT	Mallinckrodt Critical Care	1986-07-31	17	0
K860901	LASER RESISTANT TRACHEAL TUBE (TENTATIVE)	Mallinckrodt Critical Care	1986-06-05	87	0
K861483	ANGIOGRAPHIC CATHETER (CARDIOLOGY & RADIOLOGY)	Mallinckrodt Critical Care	1986-05-15	28	0
K853182	DIAGNOSTIC INTRAVASCULAR CATHETERS	Mallinckrodt Critical Care	1986-01-15	169	0
K852413	LGT TUBE	Mallinckrodt Critical Care	1985-09-05	91	0
K852025	BRANDT TRACHEAL TUBE(TENTATIVE)	Mallinckrodt Critical Care	1985-08-13	97	0
K852493	UNCUFFED HI-LO JET TRACHEAL TUBE	Mallinckrodt Critical Care	1985-07-08	26	0
K845037	PERCUTANEOUS ANGIOGRAPHIC NEEDLES	Mallinckrodt Critical Care	1985-06-21	176	0
K844201	HI-LO TEMP THERMOCOUPLE TO THERMISTER ADAPTOR	Mallinckrodt Critical Care	1985-03-04	125	0
K844598	LARIAT CATHETER	Mallinckrodt Critical Care	1985-02-01	67	0
K843640	XENON XE 127/XE 133 GAS DISPENSER	Mallinckrodt Critical Care	1985-01-14	119	0
K841872	UNCUFFED REINFORCED TRACHEAL TUBE	Mallinckrodt Critical Care	1984-07-26	80	0
K842113	AMENDMENT TO ANGIOGRAPHY KIT W/ADDIT	Mallinckrodt Critical Care	1984-07-13	116	0
K842464	TRACHEAL TUBE/STETHOSCOPE	Mallinckrodt Critical Care	1984-07-06	11	0
K842011	CHLORIDE TEST KIT	Mallinckrodt Critical Care	1984-06-22	36	0
K840398	INLINE FOAM NOSE	Mallinckrodt Critical Care	1984-03-16	46	0
K840399	FOAM NOSE	Mallinckrodt Critical Care	1984-03-16	46	0
K834223	CARDIOVASCULAR SPRING GUIDE WIRE	Mallinckrodt Critical Care	1984-02-13	69	0
K832657	DISPOSABLE MANIFOLD SET	Mallinckrodt Critical Care	1983-11-07	91	0
K832635	HI-LO TEMP TYMPANIC TEMP. SENSOR	Mallinckrodt Critical Care	1983-10-04	61	0
K832553	POTASSIUM TEST KIT	Mallinckrodt Critical Care	1983-09-20	50	0
K832552	SODIUM TEST KIT	Mallinckrodt Critical Care	1983-09-20	50	0
K832288	HEMOGLOBINOMETER	Mallinckrodt Critical Care	1983-09-01	50	0
K831567	FOLEY-TEMP	Mallinckrodt Critical Care	1983-08-10	86	0
K831509	ANGIOGRAPHY KIT W/ADDIT. COMPONENTS	Mallinckrodt Critical Care	1983-06-08	28	0
K830631	TRACHEAL TUBE W/ILLUMINATING LOCATER	Mallinckrodt Critical Care	1983-05-09	69	0
K830415	DIAGNOSTIC INTRAVASCULAR CATHETER	Mallinckrodt Critical Care	1983-04-28	79	0
K830229	ROENTGENOGRAPHY SET	Mallinckrodt Critical Care	1983-03-09	44	0
K823886	PROFILE 750 BLOOD CELL COUNTER	Mallinckrodt Critical Care	1983-03-01	64	0
K822159	ANGIOUROGRAPHY KIT	Mallinckrodt Critical Care	1982-11-03	103	0
K822640	CORONARY INFUSION KIT	Mallinckrodt Critical Care	1982-09-28	27	0
K821151	RIA-QUANT FPA TEST KIT	Mallinckrodt Critical Care	1982-07-22	87	0
K821833	HI-LO TEMP SKIN TEMPERATURE SENSOR	Mallinckrodt Critical Care	1982-07-20	28	0
K821976	ANGIOGRAPHY KIT	Mallinckrodt Critical Care	1982-07-20	14	0
K820725	SPAC T4 RIA TEST KIT	Mallinckrodt Critical Care	1982-06-01	76	0
K820001	CORONARY INFUSION KIT	Mallinckrodt Critical Care	1982-01-29	25	0
K812689	RIA QUANT C-PEPTIDE KIT	Mallinckrodt Critical Care	1981-10-06	14	0
K812690	C-PEPTIDE CONTROL PACK	Mallinckrodt Critical Care	1981-10-06	14	0
K812000	PEDIATRIC DOUBLE SWIVEL CONNECTOR	Mallinckrodt Critical Care	1981-08-03	20	0
K811888	LINDHOLM ANATOMICAL TRACHEAL TUBE	Mallinckrodt Critical Care	1981-07-23	22	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