# Augustine Medical, Inc.

- Location (FDA's records): Eden Prairie, MN
- FDA decisions: 25 (1987–2002): 25 510(k) clearances
- Product codes: DWJ (12), CCW (5), BSR (3), MSA (2), BSB (1), JOW (1), LHC (1)
- Predicates its devices cite: 6 (2 its own); citations of its devices by later devices: 29 (2 its own)
- Recalls linked to its devices: 4 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Ndm Acquisition Corp.: 1 (https://510kreport.com/company/ndm-acquisition)
- New Dimensions IN Medicine, Inc.: 1 (https://510kreport.com/company/new-dimensions-in-medicine)
- Acme United Corp.: 1 (https://510kreport.com/company/acme-united)
- Seabrook Medical Systems, Inc.: 1 (https://510kreport.com/company/seabrook-medical-systems)

## Firms that cite its devices most
- Arizant Healthcare, Inc.: 8 (https://510kreport.com/company/arizant-healthcare)
- Augustine Biomedical & Design, LLC: 2 (https://510kreport.com/company/augustine-biomedical-design)
- Estill Medical Technologies, Inc.: 2 (https://510kreport.com/company/estill-medical-technologies)
- Galmaz Biotech S.L.: 2 (https://510kreport.com/company/galmaz-biotech)
- American Healthcare Products, Inc.: 1 (https://510kreport.com/company/american-healthcare-products)
- Iob Medical, Inc.: 1 (https://510kreport.com/company/iob-medical)
- Smith Medical Asd, Inc.: 1 (https://510kreport.com/company/smith-medical-asd)
- The Smithworks Company: 1 (https://510kreport.com/company/smithworks)

## Its most-cited devices
- K001149: Augustine Medical Bair Huuger, Model 750 Total Temperature Management System-(Model 750 Warming Unit, Bair Hugger Blank (2000), cited by 10
- K973741: Bair Hugger Blood/Fluid Warmer (1998), cited by 7
- K960167: System, Thermal Regulating 74-DWJ (1996), cited by 4
- K021473: Bair Hugger Temperature Management System (2002), cited by 2
- K903360: Bair Hugger (R) Patient Warming System-Modification (1990), cited by 2
- K873745: Bair Hugger (TM) - Patient Warming System (1987), cited by 2

## Recent decisions
- K021473: Bair Hugger Temperature Management System (Jul 9, 2002)
- K020077: Modification to Augustine Medical Wound Care System, Model 68XXX (Jan 31, 2002)
- K001149: Augustine Medical Bair Huuger, Model 750 Total Temperature Management System-(Model 750 Warming Unit, Bair Hugger Blank (Sep 6, 2000)
- K973741: Bair Hugger Blood/Fluid Warmer (Apr 30, 1998)
- K964673: Bair Hugger Model 630 Cardiac Blanket (Jun 26, 1997)
- K963293: Augustine Medical Wound Care System Model 68XXX (Mar 28, 1997)
- K963672: Model 90022 Rolling Stand (Jan 6, 1997)
- K960167: System, Thermal Regulating 74-DWJ (Jun 17, 1996)

Source page: https://510kreport.com/company/augustine-medical