FDA product code KZL: Device, Warming. Blood And Plasma
KZL is the FDA product code for device, warming. blood and plasma. It is a Class II device, regulated under 21 CFR 864.9205 and reviewed by the Hematology panel. FDA has cleared 4 510(k) submissions under KZL, from 3 different applicants. The average 510(k) review took 68 days (median 67).
Classification
| Field | Value |
|---|---|
| Device name | Device, Warming. Blood And Plasma |
| 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 KZL clearance
Top KZL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Cryosan, Inc. | 2 | 1982-03-04 |
| Chroma Products, Inc. | 1 | 1980-05-08 |
| Vickers America Medical Corp. | 1 | 1979-09-04 |
Most recent KZL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K813489 | Cryosan, Inc. | ROCKING/CIRCULATING CYTO-THERM II 3570 | 1982-03-04 | 93 |
| K812311 | Cryosan, Inc. | CIRCULATING CYTO-THERMS | 1981-09-16 | 30 |
| K800699 | Chroma Products, Inc. | FLO TEM (FLUID WARNER) | 1980-05-08 | 41 |
| K790936 | Vickers America Medical Corp. | MODEL 114 TREONIC H150 HAEMOHEATER | 1979-09-04 | 109 |
Recalls for KZL devices
openFDA lists no recalls for product code KZL.
Frequently asked questions
What is FDA product code KZL?
KZL is the FDA product code for device, warming. blood and plasma. It is a Class II device, regulated under 21 CFR 864.9205 and reviewed by the Hematology panel.
What device class is KZL?
Class II, regulation 21 CFR 864.9205. Typical premarket route: 510(k).
How long does a 510(k) take for product code KZL?
Across 4 cleared submissions the average was 68 days from receipt to decision (median 67).
Which companies have the most KZL clearances?
Cryosan, Inc. (2); Chroma Products, Inc. (1); Vickers America Medical Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KZL
- Run a recall and safety report across every KZL manufacturer
- Watch product code KZL 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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