FDA product code HXX: Screwdriver
HXX is the FDA product code for screwdriver. It is a Class I device, regulated under 21 CFR 888.4540 and reviewed by the Orthopedic panel. FDA has cleared 4 510(k) submissions under HXX, from 4 different applicants. The average 510(k) review took 49 days (median 38). FDA has posted 32 recalls for HXX devices, 2 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Screwdriver |
| Device class | Class I |
| Regulation | 21 CFR 888.4540 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every HXX clearance
Top HXX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Dalton Technology, Inc. | 1 | 1990-06-13 |
| Buckman Co., Inc. | 1 | 1987-09-02 |
| Med-Tool, Inc. | 1 | 1987-07-15 |
| W. L. Gore & Associates, Inc. | 1 | 1986-09-02 |
Most recent HXX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K901166 | Dalton Technology, Inc. | DALTON TECHNOLOGY FLEXIBLE SCREWDRIVER | 1990-06-13 | 92 |
| K873066 | Buckman Co., Inc. | ACROMED SCREW DRIVER | 1987-09-02 | 28 |
| K872389 | Med-Tool, Inc. | PRECISION SCREW DRIVER SET | 1987-07-15 | 26 |
| K862689 | W. L. Gore & Associates, Inc. | 2.5MM HEX DRIVER/CURVE PASSER/BONE PUNCH/RASP | 1986-09-02 | 49 |
Recalls for HXX devices
32 product recalls in 27 recall events; 2 initiated in the last five years and 1 still open. Most recent: 2024-04-25.
| Year | Recalls |
|---|---|
| 2018 | 1 |
| 2019 | 2 |
| 2021 | 2 |
| 2024 | 1 |
Frequently asked questions
What is FDA product code HXX?
HXX is the FDA product code for screwdriver. It is a Class I device, regulated under 21 CFR 888.4540 and reviewed by the Orthopedic panel.
What device class is HXX?
Class I, regulation 21 CFR 888.4540. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HXX?
Across 4 cleared submissions the average was 49 days from receipt to decision (median 38).
Which companies have the most HXX clearances?
Dalton Technology, Inc. (1); Buckman Co., Inc. (1); Med-Tool, Inc. (1); W. L. Gore & Associates, Inc. (1).
Have HXX devices been recalled?
Yes: 32 product recalls across 27 recall events; the most recent began 2024-04-25.
Next steps
- Run an FDA pathway report with predicate devices for product code HXX
- Run a recall and safety report across every HXX manufacturer
- Watch product code HXX 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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