Browse hierarchy: [Hematology (HE)](/submissions/HE) → [Subpart J — Products Used In Establishments That Manufacture Blood and Blood Products](/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products) → [21 CFR 864.9205](/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/864.9205) → BSB — Warmer, Blood, Non-Electromagnetic Radiation

# BSB · Warmer, Blood, Non-Electromagnetic Radiation

_Hematology · 21 CFR 864.9205 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/BSB

## Overview

- **Product Code:** BSB
- **Device Name:** Warmer, Blood, Non-Electromagnetic Radiation
- **Regulation:** [21 CFR 864.9205](/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/864.9205)
- **Device Class:** 2
- **Review Panel:** [Hematology](/submissions/HE)

## Identification

A nonelectromagnetic blood and plasma warming device is a device that warms blood or plasma, by means other than electromagnetic radiation, prior to administration. An electromagnetic blood and plasma warming device is a device that employs electromagnetic radiation (radiowaves or microwaves) to warm a bag or bottle of blood or plasma prior to administration.

## Classification Rationale

Nonelectromagnetic blood and plasma warming device: Class II (performance standards). Electromagnetic blood and plasma warming device: Class III (premarket approval).

## Recent Cleared Devices (14 of 14)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K112639](https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/BSB/K112639.md) | THE BELMONT BUDDY LITE FLUID WARMER | Belmont Instrument Corp. | Nov 16, 2011 | SESE |
| [K090508](https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/BSB/K090508.md) | THE BELMONT BUDDY LITE FLUID WARMER | Belmont Instrument Corp. | Mar 26, 2009 | SESE |
| [K062774](https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/BSB/K062774.md) | BELMONT BUDDY PLUS FLUID WARMER | Belmont Instrument Corp. | Oct 19, 2006 | SESE |
| [K052547](https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/BSB/K052547.md) | BELMONT BUDDY FLUID WARMER | Belmont Instrument Corp. | Oct 13, 2005 | SESE |
| [K031478](https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/BSB/K031478.md) | MICROHEATER | Belmont Instrument Corp. | Jul 2, 2003 | SESE |
| [K020060](https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/BSB/K020060.md) | ASTOFLO | Nats Corp. | Mar 5, 2002 | SESE |
| [K012031](https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/BSB/K012031.md) | MODIFICATION TO THERMAL ANGEL | Estill Medical Technologies, Inc. | Jul 26, 2001 | SESE |
| [K991159](https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/BSB/K991159.md) | PRISMATHERM II, ASTOLINE | Stihler Electronic GmbH | Sep 3, 1999 | SESE |
| [K991160](https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/BSB/K991160.md) | ASTOTHERM PLUS, ASTOTUBES, ASTOLINE | Stihler Electronic GmbH | Sep 2, 1999 | SESE |
| [K984640](https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/BSB/K984640.md) | THERMAL ANGEL | Estill Medical Technologies, Inc. | Jul 1, 1999 | SESE |
| [K973741](https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/BSB/K973741.md) | BAIR HUGGER BLOOD/FLUID WARMER | Augustine Medical, Inc. | Apr 30, 1998 | SESE |
| [K953741](https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/BSB/K953741.md) | THERMACYL BLOOD/FLUID WARMER | Baxter Healthcare Corp | Jun 26, 1996 | SESE |
| [K770232](https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/BSB/K770232.md) | BLOOD/FLUID WARMER MODEL DW-1000A | Gorman Rupp Industries | Feb 14, 1977 | SESE |
| [K760012](https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/BSB/K760012.md) | BLOOD WARMER (CODE 4R4305) | Travenol Laboratories, S.A. | Jul 16, 1976 | SESE |

## Top Applicants

- Belmont Instrument Corp. — 5 clearances
- Estill Medical Technologies, Inc. — 2 clearances
- Stihler Electronic GmbH — 2 clearances
- Augustine Medical, Inc. — 1 clearance
- Baxter Healthcare Corp — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/BSB](https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/BSB)

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