FDA product code KSE: Refrigerator, Freezer, Blood Storage
KSE is the FDA product code for refrigerator, freezer, blood storage. It is a Class II device, regulated under 21 CFR 864.9700 and reviewed by the Hematology panel. FDA has cleared 4 510(k) submissions under KSE, from 4 different applicants. The average 510(k) review took 29 days (median 29).
Classification
| Field | Value |
|---|---|
| Device name | Refrigerator, Freezer, Blood Storage |
| Device class | Class II |
| Regulation | 21 CFR 864.9700 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every KSE clearance
Top KSE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Harris Mfg. Co. | 1 | 1988-12-02 |
| Separation Science Corp. | 1 | 1981-12-31 |
| Marion Laboratories, Inc. | 1 | 1980-10-10 |
| Liquid Crystal Products, Inc. | 1 | 1980-04-16 |
Most recent KSE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K884436 | Harris Mfg. Co. | MODIFIED LOW-TEMP. FREEZER MODEL HLT-80LS-85 | 1988-12-02 | 42 |
| K813327 | Separation Science Corp. | SEPCOR TEMPERATURE MONITOR | 1981-12-31 | 37 |
| K802319 | Marion Laboratories, Inc. | HEMOTEMP TM | 1980-10-10 | 17 |
| K800667 | Liquid Crystal Products, Inc. | MONITEMP BLOOD PACK TEMP. MONITOR | 1980-04-16 | 21 |
Recalls for KSE devices
openFDA lists no recalls for product code KSE.
Frequently asked questions
What is FDA product code KSE?
KSE is the FDA product code for refrigerator, freezer, blood storage. It is a Class II device, regulated under 21 CFR 864.9700 and reviewed by the Hematology panel.
What device class is KSE?
Class II, regulation 21 CFR 864.9700. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KSE?
Across 4 cleared submissions the average was 29 days from receipt to decision (median 29).
Which companies have the most KSE clearances?
Harris Mfg. Co. (1); Separation Science Corp. (1); Marion Laboratories, Inc. (1); Liquid Crystal Products, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KSE
- Run a recall and safety report across every KSE manufacturer
- Watch product code KSE 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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