FDA product code KQZ: Component, Traction, Non-Invasive
KQZ is the FDA product code for component, traction, non-invasive. It is a Class I device, regulated under 21 CFR 888.5890 and reviewed by the Orthopedic panel. FDA has cleared 11 510(k) submissions under KQZ, from 10 different applicants. The average 510(k) review took 33 days (median 27). FDA has posted 9 recalls for KQZ devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Component, Traction, Non-Invasive |
| Device class | Class I |
| Regulation | 21 CFR 888.5890 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every KQZ clearance
Top KQZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Warm & Form, Orthopedic Materials | 2 | 1982-12-30 |
| Technol, Inc. | 1 | 1988-10-11 |
| Tecnol New Jersey Wound Care, Inc. | 1 | 1988-07-27 |
| Avec Scientific Design Corp. | 1 | 1987-06-16 |
| The Kendal Co. | 1 | 1987-04-15 |
5 more applicants have KQZ clearances. See the full list in Caduvo.
Most recent KQZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K884132 | Technol, Inc. | TECNOL BUCKS TRACTION W/HEEL PROTECTOR | 1988-10-11 | 11 |
| K882640 | Tecnol New Jersey Wound Care, Inc. | TECNOL SECURE-ALL PELVIC TRACTION BELT | 1988-07-27 | 30 |
| K871900 | Avec Scientific Design Corp. | OVER DRAPE LEG HOLDER | 1987-06-16 | 32 |
| K871296 | The Kendal Co. | T.E.D.(TM) TRACTION DEVICE | 1987-04-15 | 15 |
| K854270 | Comfortex, Inc. | MURPHY ADJUSTABLE SPLINT | 1985-12-09 | 47 |
Recalls for KQZ devices
9 product recalls in 3 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2021-12-14.
| Year | Recalls |
|---|---|
| 2018 | 2 |
| 2021 | 1 |
Frequently asked questions
What is FDA product code KQZ?
KQZ is the FDA product code for component, traction, non-invasive. It is a Class I device, regulated under 21 CFR 888.5890 and reviewed by the Orthopedic panel.
What device class is KQZ?
Class I, regulation 21 CFR 888.5890. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KQZ?
Across 11 cleared submissions the average was 33 days from receipt to decision (median 27).
Which companies have the most KQZ clearances?
Warm & Form, Orthopedic Materials (2); Technol, Inc. (1); Tecnol New Jersey Wound Care, Inc. (1); Avec Scientific Design Corp. (1); The Kendal Co. (1).
Have KQZ devices been recalled?
Yes: 9 product recalls across 3 recall events; the most recent began 2021-12-14.
Next steps
- Run an FDA pathway report with predicate devices for product code KQZ
- Run a recall and safety report across every KQZ manufacturer
- Watch product code KQZ 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.
All Orthopedic product codes · FDA product code lookup · 510(k) database search · 510(k) review times