# Mallinckrodt Critical Care

- Location (FDA's records): Mchenry, IL
- FDA decisions: 92 (1976–1989): 92 510(k) clearances
- Product codes: BTR (10), DQO (9), FLL (7), JJX (4), CFR (2), IYT (2), JIX (2), CDX (2), KOD (2), BYD (2), GKL (2), GIF (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 13 (0 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Covidien: 3 (https://510kreport.com/company/covidien)
- Mallinckrodt Medical: 2 (https://510kreport.com/company/mallinckrodt-medical)
- Fuji Systems Corp.: 1 (https://510kreport.com/company/fuji-systems)
- Vitaid, Ltd.: 1 (https://510kreport.com/company/vitaid)
- Rusch Intl.: 1 (https://510kreport.com/company/rusch-intl)
- Well Lead Instruments: 1 (https://510kreport.com/company/well-lead-instruments)
- Spiritus Technologies, LLC: 1 (https://510kreport.com/company/spiritus-technologies)
- Kendall Healthcare Products Co. Div.Of Tyco Health: 1 (https://510kreport.com/company/kendall-healthcare-products-co-div-of-tyco-health)

## Its most-cited devices
- K871204: Cuffed Tracheal Tube (Multiple) (1987), cited by 5
- K771219: Broncho-Cath (1977), cited by 3
- K811862: HI-LO Temp Esophageal Stethoscope (1981), cited by 1
- K852025: Brandt Tracheal Tube (Tentative) (1985), cited by 1
- K874514: HI-LO Temp (R) General Purpose Temperature Probe (1988), cited by 1
- K873004: Guiding Catheter (1987), cited by 1

## Recent decisions
- K880343: Burney Gallbladder Catheter Kit (May 1, 1989)
- K874605: HI-LO Temp (R) Myocardial Temperature Sensor (Feb 2, 1988)
- K874514: HI-LO Temp (R) General Purpose Temperature Probe (Jan 29, 1988)
- K874568: HI-LO Temp (R) Model 8700 Patient Temp Monitor (Jan 6, 1988)
- K873461: Laser-Flex (TM) Tracheal Tube (Cuffed) (Nov 6, 1987)
- K874404: HI-LO Temp (R) Skin Temperature Sensor (Nov 6, 1987)
- K873833: Thermocouple Adapter (Nov 3, 1987)
- K873004: Guiding Catheter (Sep 15, 1987)

Source page: https://510kreport.com/company/mallinckrodt-critical-care