FDA product code HJN: Transilluminator, Battery-Powered
HJN is the FDA product code for transilluminator, battery-powered. It is a Class I device, regulated under 21 CFR 886.1945 and reviewed by the Ophthalmic panel. FDA has cleared 3 510(k) submissions under HJN, from 3 different applicants. The average 510(k) review took 107 days (median 70). FDA has posted 1 recall for HJN devices.
Classification
| Field | Value |
|---|---|
| Device name | Transilluminator, Battery-Powered |
| Device class | Class I |
| 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 HJN clearance
Top HJN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Trinity Partners, LLC | 1 | 1994-05-16 |
| Lumitex, Inc. | 1 | 1991-12-24 |
| Sylvan Corp. | 1 | 1990-05-24 |
Most recent HJN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K941035 | Trinity Partners, LLC | VENOSCOPE | 1994-05-16 | 70 |
| K912747 | Lumitex, Inc. | LULMITEX NEONATAL TRANSILLUMINATOR | 1991-12-24 | 186 |
| K901309 | Sylvan Corp. | SYLVAN PEDIASCAN 200 TRANSILLUMINATOR | 1990-05-24 | 65 |
Recalls for HJN devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2005-04-28.
Frequently asked questions
What is FDA product code HJN?
HJN is the FDA product code for transilluminator, battery-powered. It is a Class I device, regulated under 21 CFR 886.1945 and reviewed by the Ophthalmic panel.
What device class is HJN?
Class I, regulation 21 CFR 886.1945. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HJN?
Across 3 cleared submissions the average was 107 days from receipt to decision (median 70).
Which companies have the most HJN clearances?
Trinity Partners, LLC (1); Lumitex, Inc. (1); Sylvan Corp. (1).
Have HJN devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2005-04-28.
Next steps
- Run an FDA pathway report with predicate devices for product code HJN
- Run a recall and safety report across every HJN manufacturer
- Watch product code HJN 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 Ophthalmic product codes · FDA product code lookup · 510(k) database search · 510(k) review times