FDA product code HMJ: Screen, Tangent, Projection, Battery-Powered
HMJ is the FDA product code for screen, tangent, projection, battery-powered. It is a Class I device, regulated under 21 CFR 886.1810 and reviewed by the Ophthalmic panel. FDA has cleared 2 510(k) submissions under HMJ. The average 510(k) review took 101 days (median 101).
Classification
| Field | Value |
|---|---|
| Device name | Screen, Tangent, Projection, Battery-Powered |
| Device class | Class I |
| Regulation | 21 CFR 886.1810 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every HMJ clearance
Top HMJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Bioenterics Corp. | 2 | 1993-12-16 |
Most recent HMJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K934084 | Bioenterics Corp. | BIOENTERICS ENDOLUMINA ILLUMINATING BOUGIE | 1993-12-16 | 118 |
| K924753 | Bioenterics Corp. | BIOENTRICS ENDOLUMINA ILLUMINATED BOUGIE | 1992-12-15 | 84 |
Recalls for HMJ devices
openFDA lists no recalls for product code HMJ.
Frequently asked questions
What is FDA product code HMJ?
HMJ is the FDA product code for screen, tangent, projection, battery-powered. It is a Class I device, regulated under 21 CFR 886.1810 and reviewed by the Ophthalmic panel.
What device class is HMJ?
Class I, regulation 21 CFR 886.1810. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HMJ?
Across 2 cleared submissions the average was 101 days from receipt to decision (median 101).
Which companies have the most HMJ clearances?
Bioenterics Corp. (2).
Next steps
- Run an FDA pathway report with predicate devices for product code HMJ
- Run a recall and safety report across every HMJ manufacturer
- Watch product code HMJ 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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