FDA product code KQW: Goniometer, Nonpowered
KQW is the FDA product code for goniometer, nonpowered. It is a Class I device, regulated under 21 CFR 888.1520 and reviewed by the Neurology panel. FDA has cleared 13 510(k) submissions under KQW, from 6 different applicants. The average 510(k) review took 51 days (median 43).
Classification
| Field | Value |
|---|---|
| Device name | Goniometer, Nonpowered |
| Device class | Class I |
| Regulation | 21 CFR 888.1520 |
| Review panel | NE — Neurology |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every KQW clearance
Top KQW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Fred Sammons, Inc. | 8 | 1983-06-24 |
| Sgarlato Laboratories, Inc. | 1 | 1993-08-02 |
| Biosearch Medical Products, Inc. | 1 | 1990-07-03 |
| Twin City Surgical, Inc. | 1 | 1987-03-17 |
| Chattanooga Group, Inc. | 1 | 1985-04-04 |
1 more applicants have KQW clearances. See the full list in Caduvo.
Most recent KQW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K926237 | Sgarlato Laboratories, Inc. | O'BRIEN GONIOMETER | 1993-08-02 | 234 |
| K901744 | Biosearch Medical Products, Inc. | DOBBHOFF(R) RETRIEVAL FORCEPS | 1990-07-03 | 77 |
| K870767 | Twin City Surgical, Inc. | THE (CROM) TESTER | 1987-03-17 | 19 |
| K850082 | Chattanooga Group, Inc. | HAND HELD GONIOMETER | 1985-04-04 | 84 |
| K831550 | Fred Sammons, Inc. | FINGER BONIOMETER BK7506 | 1983-06-24 | 43 |
Recalls for KQW devices
openFDA lists no recalls for product code KQW.
Frequently asked questions
What is FDA product code KQW?
KQW is the FDA product code for goniometer, nonpowered. It is a Class I device, regulated under 21 CFR 888.1520 and reviewed by the Neurology panel.
What device class is KQW?
Class I, regulation 21 CFR 888.1520. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KQW?
Across 13 cleared submissions the average was 51 days from receipt to decision (median 43).
Which companies have the most KQW clearances?
Fred Sammons, Inc. (8); Sgarlato Laboratories, Inc. (1); Biosearch Medical Products, Inc. (1); Twin City Surgical, Inc. (1); Chattanooga Group, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KQW
- Run a recall and safety report across every KQW manufacturer
- Watch product code KQW 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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