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) → KZL — Device, Warming. Blood And Plasma

# KZL · Device, Warming. Blood And Plasma

_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/KZL

## Overview

- **Product Code:** KZL
- **Device Name:** Device, Warming. Blood And Plasma
- **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 (4 of 4)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K813489](https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KZL/K813489.md) | ROCKING/CIRCULATING CYTO-THERM II 3570 | Cryosan, Inc. | Mar 4, 1982 | SESE |
| [K812311](https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KZL/K812311.md) | CIRCULATING CYTO-THERMS | Cryosan, Inc. | Sep 16, 1981 | SESE |
| [K800699](https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KZL/K800699.md) | FLO TEM (FLUID WARNER) | Chroma Products, Inc. | May 8, 1980 | SESE |
| [K790936](https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KZL/K790936.md) | MODEL 114 TREONIC H150 HAEMOHEATER | Vickers America Medical Corp. | Sep 4, 1979 | SESE |

## Top Applicants

- Cryosan, Inc. — 2 clearances
- Chroma Products, Inc. — 1 clearance
- Vickers America Medical 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/KZL](https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KZL)

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