FDA product code HXL: Mallet
HXL is the FDA product code for mallet. It is a Class I device, regulated under 21 CFR 878.4800 and reviewed by the General and Plastic Surgery panel. FDA has cleared 3 510(k) submissions under HXL, from 3 different applicants. The average 510(k) review took 14 days (median 14). FDA has posted 1 recall for HXL devices.
Classification
| Field | Value |
|---|---|
| Device name | Mallet |
| Device class | Class I |
| Regulation | 21 CFR 878.4800 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every HXL clearance
Top HXL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Treace Medical, Inc. | 1 | 1988-06-23 |
| New England Surgical Instrument Corp. | 1 | 1987-06-23 |
| Military Engineering, Inc. | 1 | 1987-04-06 |
Most recent HXL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K882349 | Treace Medical, Inc. | MALLET, SURGICAL | 1988-06-23 | 16 |
| K872209 | New England Surgical Instrument Corp. | ARTHROPLASTY MALLET | 1987-06-23 | 14 |
| K871195 | Military Engineering, Inc. | MALLET, BONE SURGERY, STAINLESS STEEL, 2LB. | 1987-04-06 | 13 |
Recalls for HXL devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 1 still open. Most recent: 2021-07-21.
| Year | Recalls |
|---|---|
| 2021 | 1 |
Frequently asked questions
What is FDA product code HXL?
HXL is the FDA product code for mallet. It is a Class I device, regulated under 21 CFR 878.4800 and reviewed by the General and Plastic Surgery panel.
What device class is HXL?
Class I, regulation 21 CFR 878.4800. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HXL?
Across 3 cleared submissions the average was 14 days from receipt to decision (median 14).
Which companies have the most HXL clearances?
Treace Medical, Inc. (1); New England Surgical Instrument Corp. (1); Military Engineering, Inc. (1).
Have HXL devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2021-07-21.
Next steps
- Run an FDA pathway report with predicate devices for product code HXL
- Run a recall and safety report across every HXL manufacturer
- Watch product code HXL 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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