FDA product code KQG: Instrument, Coagulation
KQG is the FDA product code for instrument, coagulation. It is a Class II device, regulated under 21 CFR 864.5400 and reviewed by the Hematology panel. FDA has cleared 14 510(k) submissions under KQG, from 11 different applicants. The average 510(k) review took 110 days (median 86). FDA has posted 1 recall for KQG devices.
Classification
| Field | Value |
|---|---|
| Device name | Instrument, Coagulation |
| Device class | Class II |
| Regulation | 21 CFR 864.5400 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every KQG clearance
Top KQG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Pacific Hemostasis | 2 | 1999-09-03 |
| Med USA | 2 | 1986-09-29 |
| Volu Sol Medical Industries | 2 | 1982-07-22 |
| Zycare | 1 | 2005-08-16 |
| Vital Scientific N.V. | 1 | 2002-10-25 |
6 more applicants have KQG clearances. See the full list in Caduvo.
Most recent KQG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K050821 | Zycare | COAGCARE ANTICOAGULATION MANAGEMENT SYSTEM | 2005-08-16 | 138 |
| K021976 | Vital Scientific N.V. | FIBRON-1, FIBRON-4, QUIKCOAG, FIBRON | 2002-10-25 | 130 |
| K992130 | Pacific Hemostasis | PACIFIC HEMOSTASIS THROMBOSCREEN 400C | 1999-09-03 | 72 |
| K991321 | Pacific Hemostasis | PACIFIC HEMOSTASIS THROMBOSCREEN 200 | 1999-06-21 | 63 |
| K983475 | International Technidyne Corp. | HEMOCHRON RESPONSE | 1999-05-03 | 213 |
Recalls for KQG devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2010-11-30.
Frequently asked questions
What is FDA product code KQG?
KQG is the FDA product code for instrument, coagulation. It is a Class II device, regulated under 21 CFR 864.5400 and reviewed by the Hematology panel.
What device class is KQG?
Class II, regulation 21 CFR 864.5400. Typical premarket route: 510(k).
How long does a 510(k) take for product code KQG?
Across 14 cleared submissions the average was 110 days from receipt to decision (median 86).
Which companies have the most KQG clearances?
Pacific Hemostasis (2); Med USA (2); Volu Sol Medical Industries (2); Zycare (1); Vital Scientific N.V. (1).
Have KQG devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2010-11-30.
Next steps
- Run an FDA pathway report with predicate devices for product code KQG
- Run a recall and safety report across every KQG manufacturer
- Watch product code KQG 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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