# Cobe Laboratories, Inc.

- Location (FDA's records): Mchenry, IL
- FDA decisions: 77 (1976–1993): 77 510(k) clearances
- Product codes: DTZ (6), FJI (6), FKP (4), FJG (4), DTR (3), DTQ (3), DTN (3), KDI (2), JOD (2), CAC (2), DSY (2), KRL (2)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 16 (0 its own)
- Recalls linked to its devices: 47 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Maquet Cardiopulmonary, AG: 2 (https://510kreport.com/company/maquet-cardiopulmonary)
- Vortex Medical, Inc.: 2 (https://510kreport.com/company/vortex-medical)
- Haidylena Medical Egypt: 1 (https://510kreport.com/company/haidylena-medical-egypt)
- Haemonetics Corp.: 1 (https://510kreport.com/company/haemonetics)
- Fenwal, Inc.: 1 (https://510kreport.com/company/fenwal)
- Clary Corp.: 1 (https://510kreport.com/company/clary)
- Chalice Medical, Ltd.: 1 (https://510kreport.com/company/chalice-medical)
- B.Braun Medical, Inc.: 1 (https://510kreport.com/company/b-braun-medical)

## Its most-cited devices
- K771692: Tubing Sets (1977), cited by 3
- K900105: Cobe Spectra Blood Component Separator Therapeutic (1991), cited by 3
- K864831: Cobe Centrysystem 145E,160E,175E,190E Dialyzers (1987), cited by 2
- K881330: Cobe Heart/Lung Perfusion and Cardioplegia Pack (1988), cited by 2
- K823338: Cobe Hemoconcentrator 1.3 (1983), cited by 1
- K760624: Small Vessel Cannula (1976), cited by 1

## Recent decisions
- K923272: Cobe CMS-HF Hollow Fiber Membrane Oxygenator (May 11, 1993)
- K900105: Cobe Spectra Blood Component Separator Therapeutic (Mar 22, 1991)
- K905793: Cobe Centry 2 Bicart Option Kit (Feb 12, 1991)
- K905388: Cobe Centrysystem 3 Bicart Option Kit (Feb 11, 1991)
- K904336: New Cobe Saturation/Hematocrit Monitor (Dec 27, 1990)
- K902437: Cobe Cardiotomy Reservoir with or Without Filter (Dec 17, 1990)
- K902631: Cobe Icu Conversion Kit (Dec 17, 1990)
- K904566: New Cobe Centrysystem (TM) 100 HG Dialyzer (Dec 12, 1990)

Source page: https://510kreport.com/company/cobe-laboratories