FDA product code HWA: Impactor
HWA is the FDA product code for impactor. 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 HWA, from 4 different applicants. The average 510(k) review took 85 days (median 72). FDA has posted 27 recalls for HWA devices, 4 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Impactor |
| 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 HWA clearance
Top HWA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Mira, Inc. | 1 | 1994-01-25 |
| Cedar Surgical, Inc. | 1 | 1986-11-24 |
| Plastafil, Inc. | 1 | 1984-08-27 |
| Depuy, Inc. | 1 | 1977-02-08 |
Most recent HWA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K933527 | Mira, Inc. | MODIFICATION OF ANTERIOR SEGMENT ELECTRODES | 1994-01-25 | 189 |
| K864422 | Cedar Surgical, Inc. | RAYLOR(TM) MALLET | 1986-11-24 | 14 |
| K841627 | Plastafil, Inc. | MALLET | 1984-08-27 | 130 |
| K770205 | Depuy, Inc. | CEMENT CHISELS | 1977-02-08 | 8 |
Recalls for HWA devices
27 product recalls in 22 recall events; 4 initiated in the last five years and 4 still open. Most recent: 2026-02-03.
| Year | Recalls |
|---|---|
| 2017 | 3 |
| 2019 | 2 |
| 2020 | 1 |
| 2023 | 1 |
| 2024 | 1 |
| 2026 | 2 |
Frequently asked questions
What is FDA product code HWA?
HWA is the FDA product code for impactor. It is a Class I device, regulated under 21 CFR 888.4540 and reviewed by the Orthopedic panel.
What device class is HWA?
Class I, regulation 21 CFR 888.4540. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HWA?
Across 4 cleared submissions the average was 85 days from receipt to decision (median 72).
Which companies have the most HWA clearances?
Mira, Inc. (1); Cedar Surgical, Inc. (1); Plastafil, Inc. (1); Depuy, Inc. (1).
Have HWA devices been recalled?
Yes: 27 product recalls across 22 recall events; the most recent began 2026-02-03.
Next steps
- Run an FDA pathway report with predicate devices for product code HWA
- Run a recall and safety report across every HWA manufacturer
- Watch product code HWA 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