FDA product code KSY: Boxes, View, Blood Grouping
KSY is the FDA product code for boxes, view, blood grouping. It is a Class I device, regulated under 21 CFR 864.9185 and reviewed by the Hematology panel. FDA has cleared 1 510(k) submission under KSY. The average 510(k) review took 18 days (median 18).
Classification
| Field | Value |
|---|---|
| Device name | Boxes, View, Blood Grouping |
| Device class | Class I |
| Regulation | 21 CFR 864.9185 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every KSY clearance
Top KSY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Tekpro | 1 | 1979-12-04 |
Most recent KSY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K792306 | Tekpro | RH VIEWBOX | 1979-12-04 | 18 |
Recalls for KSY devices
openFDA lists no recalls for product code KSY.
Frequently asked questions
What is FDA product code KSY?
KSY is the FDA product code for boxes, view, blood grouping. It is a Class I device, regulated under 21 CFR 864.9185 and reviewed by the Hematology panel.
What device class is KSY?
Class I, regulation 21 CFR 864.9185. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KSY?
Across 1 cleared submissions the average was 18 days from receipt to decision (median 18).
Which companies have the most KSY clearances?
Tekpro (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KSY
- Run a recall and safety report across every KSY manufacturer
- Watch product code KSY 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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