FDA product code KSW: System, Processing For Frozen Blood
KSW is the FDA product code for system, processing for frozen blood. It is a Class II device, regulated under 21 CFR 864.9145 and reviewed by the Hematology panel. FDA has cleared 1 510(k) submission under KSW. The average 510(k) review took 27 days (median 27).
Classification
| Field | Value |
|---|---|
| Device name | System, Processing For Frozen Blood |
| Device class | Class II |
| Regulation | 21 CFR 864.9145 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every KSW clearance
Top KSW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Travenol Laboratories, S.A. | 1 | 1976-11-23 |
Most recent KSW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K760914 | Travenol Laboratories, S.A. | DOUBLE ELUTRA-PACK UNIT | 1976-11-23 | 27 |
Recalls for KSW devices
openFDA lists no recalls for product code KSW.
Frequently asked questions
What is FDA product code KSW?
KSW is the FDA product code for system, processing for frozen blood. It is a Class II device, regulated under 21 CFR 864.9145 and reviewed by the Hematology panel.
What device class is KSW?
Class II, regulation 21 CFR 864.9145. Typical premarket route: 510(k).
How long does a 510(k) take for product code KSW?
Across 1 cleared submissions the average was 27 days from receipt to decision (median 27).
Which companies have the most KSW clearances?
Travenol Laboratories, S.A. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KSW
- Run a recall and safety report across every KSW manufacturer
- Watch product code KSW 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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