FDA product code KSQ: Device, Blood Mixing And Blood Weighing
KSQ is the FDA product code for device, blood mixing and blood weighing. It is a Class I device, regulated under 21 CFR 864.9195 and reviewed by the Hematology panel. FDA has cleared 8 510(k) submissions under KSQ, from 6 different applicants. The average 510(k) review took 42 days (median 43).
Classification
| Field | Value |
|---|---|
| Device name | Device, Blood Mixing And Blood Weighing |
| Device class | Class I |
| Regulation | 21 CFR 864.9195 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every KSQ clearance
Top KSQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Helmer Labs, Inc. | 2 | 1981-09-29 |
| Lifeline Instruments, Inc. | 2 | 1981-04-07 |
| R&D Systems, Inc. | 1 | 1984-08-17 |
| Separation Science Corp. | 1 | 1982-05-07 |
| Royco Instruments | 1 | 1980-02-06 |
1 more applicants have KSQ clearances. See the full list in Caduvo.
Most recent KSQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K842746 | R&D Systems, Inc. | HYCEL ROTOR-MIXER AND/OR MULTI | 1984-08-17 | 35 |
| K820712 | Separation Science Corp. | SEPCOR UNIT COLLECTION MONITOR | 1982-05-07 | 53 |
| K812533 | Helmer Labs, Inc. | PLATELET AGITATOR | 1981-09-29 | 27 |
| K810617 | Lifeline Instruments, Inc. | MOBILE MATIC AUTOMATIC DONOR SCALE | 1981-04-07 | 29 |
| K802608 | Helmer Labs, Inc. | HEMATIC BLOOD MIXER | 1980-12-11 | 51 |
Recalls for KSQ devices
openFDA lists no recalls for product code KSQ.
Frequently asked questions
What is FDA product code KSQ?
KSQ is the FDA product code for device, blood mixing and blood weighing. It is a Class I device, regulated under 21 CFR 864.9195 and reviewed by the Hematology panel.
What device class is KSQ?
Class I, regulation 21 CFR 864.9195. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KSQ?
Across 8 cleared submissions the average was 42 days from receipt to decision (median 43).
Which companies have the most KSQ clearances?
Helmer Labs, Inc. (2); Lifeline Instruments, Inc. (2); R&D Systems, Inc. (1); Separation Science Corp. (1); Royco Instruments (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KSQ
- Run a recall and safety report across every KSQ manufacturer
- Watch product code KSQ 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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