FDA product code BSB: Warmer, Blood, Non-Electromagnetic Radiation
BSB is the FDA product code for warmer, blood, non-electromagnetic radiation. It is a Class II device, regulated under 21 CFR 864.9205 and reviewed by the Hematology panel. FDA has cleared 14 510(k) submissions under BSB, from 8 different applicants. The average 510(k) review took 96 days (median 54). FDA has posted 2 recalls for BSB devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Warmer, Blood, Non-Electromagnetic Radiation |
| Device class | Class II |
| Regulation | 21 CFR 864.9205 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every BSB clearance
Top BSB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Belmont Instrument Corp. | 5 | 2011-11-16 |
| Estill Medical Technologies, Inc. | 2 | 2001-07-26 |
| Stihler Electronic GmbH | 2 | 1999-09-03 |
| Nats Corp. | 1 | 2002-03-05 |
| Augustine Medical, Inc. | 1 | 1998-04-30 |
3 more applicants have BSB clearances. See the full list in Caduvo.
Most recent BSB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K112639 | Belmont Instrument Corp. | THE BELMONT BUDDY LITE FLUID WARMER | 2011-11-16 | 65 |
| K090508 | Belmont Instrument Corp. | THE BELMONT BUDDY LITE FLUID WARMER | 2009-03-26 | 28 |
| K062774 | Belmont Instrument Corp. | BELMONT BUDDY PLUS FLUID WARMER | 2006-10-19 | 31 |
| K052547 | Belmont Instrument Corp. | BELMONT BUDDY FLUID WARMER | 2005-10-13 | 27 |
| K031478 | Belmont Instrument Corp. | MICROHEATER | 2003-07-02 | 51 |
Recalls for BSB devices
2 product recalls in 2 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2025-04-10.
| Year | Recalls |
|---|---|
| 2025 | 1 |
Frequently asked questions
What is FDA product code BSB?
BSB is the FDA product code for warmer, blood, non-electromagnetic radiation. It is a Class II device, regulated under 21 CFR 864.9205 and reviewed by the Hematology panel.
What device class is BSB?
Class II, regulation 21 CFR 864.9205. Typical premarket route: 510(k).
How long does a 510(k) take for product code BSB?
Across 14 cleared submissions the average was 96 days from receipt to decision (median 54).
Which companies have the most BSB clearances?
Belmont Instrument Corp. (5); Estill Medical Technologies, Inc. (2); Stihler Electronic GmbH (2); Nats Corp. (1); Augustine Medical, Inc. (1).
Have BSB devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2025-04-10.
Next steps
- Run an FDA pathway report with predicate devices for product code BSB
- Run a recall and safety report across every BSB manufacturer
- Watch product code BSB for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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