FDA product code HIT: Tester, Color Vision
HIT is the FDA product code for tester, color vision. It is a Class I device, regulated under 21 CFR 886.1170 and reviewed by the Ophthalmic panel. FDA has cleared 9 510(k) submissions under HIT, from 8 different applicants. The average 510(k) review took 95 days (median 60).
Classification
| Field | Value |
|---|---|
| Device name | Tester, Color Vision |
| Device class | Class I |
| Regulation | 21 CFR 886.1170 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every HIT clearance
Top HIT applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Richmond Products, Inc. | 2 | 1987-12-23 |
| Gynopharma, Inc. | 1 | 1991-06-25 |
| Lkc Technologies, Inc. | 1 | 1988-02-05 |
| Titmus Optical, Inc. | 1 | 1985-01-22 |
| Luneau Laboratories | 1 | 1985-01-02 |
3 more applicants have HIT clearances. See the full list in Caduvo.
Most recent HIT clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K903001 | Gynopharma, Inc. | SLIMCATH (TM) | 1991-06-25 | 351 |
| K875026 | Lkc Technologies, Inc. | ANOMALOSCOPE PLATE TEST - 5 [APT-5] | 1988-02-05 | 60 |
| K873908 | Richmond Products, Inc. | H.R.R. PSEUDOISOCHROMATIC COLOR BLINDNESS TEST BK. | 1987-12-23 | 89 |
| K873911 | Richmond Products, Inc. | PSEUDO ISOCHROMATIC COLOR BLINDNESS TEST BOOK - 15 | 1987-12-02 | 68 |
| K844694 | Titmus Optical, Inc. | TITMUS VISION TESTER II | 1985-01-22 | 50 |
Recalls for HIT devices
openFDA lists no recalls for product code HIT.
Frequently asked questions
What is FDA product code HIT?
HIT is the FDA product code for tester, color vision. It is a Class I device, regulated under 21 CFR 886.1170 and reviewed by the Ophthalmic panel.
What device class is HIT?
Class I, regulation 21 CFR 886.1170. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HIT?
Across 9 cleared submissions the average was 95 days from receipt to decision (median 60).
Which companies have the most HIT clearances?
Richmond Products, Inc. (2); Gynopharma, Inc. (1); Lkc Technologies, Inc. (1); Titmus Optical, Inc. (1); Luneau Laboratories (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HIT
- Run a recall and safety report across every HIT manufacturer
- Watch product code HIT 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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