FDA product code KST: System, Blood Collection, Vacuum-Assisted, Manual
KST is the FDA product code for system, blood collection, vacuum-assisted, manual. It is a Class I device, regulated under 21 CFR 864.9125 and reviewed by the Hematology panel. Devices under KST reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it. FDA has posted 4 recalls for KST devices.
Classification
| Field | Value |
|---|---|
| Device name | System, Blood Collection, Vacuum-Assisted, Manual |
| Device class | Class I |
| Regulation | 21 CFR 864.9125 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) exempt |
Recalls for KST devices
4 product recalls in 4 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2015-10-01.
Frequently asked questions
What is FDA product code KST?
KST is the FDA product code for system, blood collection, vacuum-assisted, manual. It is a Class I device, regulated under 21 CFR 864.9125 and reviewed by the Hematology panel.
What device class is KST?
Class I, regulation 21 CFR 864.9125. Typical premarket route: 510(k) exempt.
Have KST devices been recalled?
Yes: 4 product recalls across 4 recall events; the most recent began 2015-10-01.
Next steps
- Run an FDA pathway report with predicate devices for product code KST
- Run a recall and safety report across every KST manufacturer
- Watch product code KST 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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