FDA product code KSS: Supplies, Blood-Bank
KSS is the FDA product code for supplies, blood-bank. It is a Class I device, regulated under 21 CFR 864.9050 and reviewed by the Hematology panel. FDA has cleared 6 510(k) submissions under KSS, from 4 different applicants. The average 510(k) review took 26 days (median 18).
Classification
| Field | Value |
|---|---|
| Device name | Supplies, Blood-Bank |
| Device class | Class I |
| Regulation | 21 CFR 864.9050 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every KSS clearance
Top KSS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Pre-Dent System | 3 | 1980-07-14 |
| U.S. Mfg. & Management, Inc. | 1 | 1988-01-05 |
| American Dade | 1 | 1981-10-27 |
| Dade, Baxter Travenol Diagnostics, Inc. | 1 | 1976-12-30 |
Most recent KSS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K874436 | U.S. Mfg. & Management, Inc. | FLUID SAMPLING PACK | 1988-01-05 | 69 |
| K812892 | American Dade | S/P SERUM DROPPER PIPETS | 1981-10-27 | 12 |
| K801516 | Pre-Dent System | PRE-DENT SYSTEM MODIFIED | 1980-07-14 | 13 |
| K801386 | Pre-Dent System | PRE-DENT SYSTEM OR PRE-DENT II | 1980-07-14 | 31 |
| K800736 | Pre-Dent System | PRE-DENT SYSTEM | 1980-04-24 | 22 |
Recalls for KSS devices
openFDA lists no recalls for product code KSS.
Frequently asked questions
What is FDA product code KSS?
KSS is the FDA product code for supplies, blood-bank. It is a Class I device, regulated under 21 CFR 864.9050 and reviewed by the Hematology panel.
What device class is KSS?
Class I, regulation 21 CFR 864.9050. Typical premarket route: 510(k).
How long does a 510(k) take for product code KSS?
Across 6 cleared submissions the average was 26 days from receipt to decision (median 18).
Which companies have the most KSS clearances?
Pre-Dent System (3); U.S. Mfg. & Management, Inc. (1); American Dade (1); Dade, Baxter Travenol Diagnostics, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KSS
- Run a recall and safety report across every KSS manufacturer
- Watch product code KSS 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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