FDA product code HJM: Transilluminator, Ac-Powered
HJM is the FDA product code for transilluminator, ac-powered. It is a Class II device, regulated under 21 CFR 886.1945 and reviewed by the Ophthalmic panel. FDA has cleared 12 510(k) submissions under HJM, from 10 different applicants. The average 510(k) review took 185 days (median 112). FDA has posted 3 recalls for HJM devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Transilluminator, Ac-Powered |
| Device class | Class II |
| Regulation | 21 CFR 886.1945 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every HJM clearance
Top HJM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Peregrine Surgical , Ltd. | 2 | 1995-06-07 |
| Radiation Measurements, Inc. | 2 | 1981-12-02 |
| Infinitech, Inc. | 1 | 1997-10-01 |
| Wells Johnson Co. | 1 | 1995-03-02 |
| Hgm, Inc. | 1 | 1994-11-10 |
5 more applicants have HJM clearances. See the full list in Caduvo.
Most recent HJM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K972506 | Infinitech, Inc. | INFINITECH BULLET ENDO ILLUMINATED PICK MANIPULATOR | 1997-10-01 | 90 |
| K950529 | Peregrine Surgical , Ltd. | PEREGRINE DIFFUSION LIGHT PIPE | 1995-06-07 | 120 |
| K945877 | Wells Johnson Co. | WECO ENDOSCOPIC SYSTEMS WITH FIBER OPTIC LIGHT | 1995-03-02 | 91 |
| K931072 | Hgm, Inc. | HGM ILLUMINATING/ASPIRATING ENDOOCULAR PROBE | 1994-11-10 | 618 |
| K933445 | Storz Instrument Co. | DPS 100 MULTIPORT ILLUMINATION SYSTEM (MIS) | 1994-09-23 | 437 |
Recalls for HJM devices
3 product recalls in 3 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2025-12-16.
| Year | Recalls |
|---|---|
| 2025 | 1 |
Frequently asked questions
What is FDA product code HJM?
HJM is the FDA product code for transilluminator, ac-powered. It is a Class II device, regulated under 21 CFR 886.1945 and reviewed by the Ophthalmic panel.
What device class is HJM?
Class II, regulation 21 CFR 886.1945. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HJM?
Across 12 cleared submissions the average was 185 days from receipt to decision (median 112).
Which companies have the most HJM clearances?
Peregrine Surgical , Ltd. (2); Radiation Measurements, Inc. (2); Infinitech, Inc. (1); Wells Johnson Co. (1); Hgm, Inc. (1).
Have HJM devices been recalled?
Yes: 3 product recalls across 3 recall events; the most recent began 2025-12-16.
Next steps
- Run an FDA pathway report with predicate devices for product code HJM
- Run a recall and safety report across every HJM manufacturer
- Watch product code HJM 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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