Augustine Medical, Inc.: FDA filings under this applicant name
FDA lists 25 510(k) clearances under the applicant name “Augustine Medical, Inc.” (first 1987, latest 2002), across 7 product codes in 5 review panels. Median 510(k) review time under this name: 92 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DWJ | System, Thermal Regulating | 12 | 12 |
| CCW | Laryngoscope, Rigid | 5 | 5 |
| BSR | Stylet, Tracheal Tube | 3 | 3 |
| MSA | Dressing, Wound And Burn, Occlusive, Heated | 2 | 2 |
| BSB | Warmer, Blood, Non-Electromagnetic Radiation | 1 | 1 |
| JOW | Sleeve, Limb, Compressible | 1 | 1 |
| LHC | Warmer, Irrigation Solution | 1 | 1 |
Review panels
- Cardiovascular (13)
- Anesthesiology (8)
- General and Plastic Surgery (2)
- Hematology (1)
- General Hospital (1)
Most recent Augustine Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K021473 | BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEM | DWJ | 2002-07-09 | 62 |
| K020077 | MODIFICATION TO AUGUSTINE MEDICAL WOUND CARE SYSTEM, MODEL 68XXX | MSA | 2002-01-31 | 22 |
| K001149 | AUGUSTINE MEDICAL BAIR HUUGER, MODEL 750 TOTAL TEMPERATURE MANAGEMENT SYSTEM-(MODEL 750 WARMING UNIT, BAIR HUGGER BLANK | DWJ | 2000-09-06 | 149 |
| K973741 | BAIR HUGGER BLOOD/FLUID WARMER | BSB | 1998-04-30 | 211 |
| K964673 | BAIR HUGGER MODEL 630 CARDIAC BLANKET | DWJ | 1997-06-26 | 217 |
| K963293 | AUGUSTINE MEDICAL WOUND CARE SYSTEM MODEL 68XXX | MSA | 1997-03-28 | 219 |
| K963672 | MODEL 90022 ROLLING STAND | JOW | 1997-01-06 | 115 |
| K960167 | SYSTEM, THERMAL REGULATING 74-DWJ | DWJ | 1996-06-17 | 153 |
| K954446 | AUGUSTINE INTUBATION GUIDE | CCW | 1995-12-29 | 95 |
| K952864 | BAIR HUGGER MODEL 655 BLANKET | DWJ | 1995-09-12 | 82 |
15 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Augustine Medical, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Augustine Temperature Management, LLC (5 510(k)s)
- Augustine Biomedical & Design, LLC (4 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Augustine Medical, Inc.?
FDA lists 25 510(k) clearances under the applicant name “Augustine Medical, Inc.” (first 1987, latest 2002), across 7 product codes in 5 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Augustine Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Augustine Medical, Inc. is 92 days.
Which FDA product codes appear under Augustine Medical, Inc.?
The most frequent FDA product codes under this applicant name are DWJ (System, Thermal Regulating, 12); CCW (Laryngoscope, Rigid, 5); BSR (Stylet, Tracheal Tube, 3).
Next steps
- See all 25 Augustine Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DWJ, Augustine Medical, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.