FDA product code HIW: Anomaloscope
HIW is the FDA product code for anomaloscope. It is a Class I device, regulated under 21 CFR 886.1070 and reviewed by the Ophthalmic panel. FDA has cleared 3 510(k) submissions under HIW, from 3 different applicants. The average 510(k) review took 170 days (median 77).
Classification
| Field | Value |
|---|---|
| Device name | Anomaloscope |
| Device class | Class I |
| Regulation | 21 CFR 886.1070 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every HIW clearance
Top HIW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Bova Intl. | 1 | 1994-02-25 |
| Lkc Technologies, Inc. | 1 | 1991-10-23 |
| Chromagraphics, Inc. | 1 | 1986-04-04 |
Most recent HIW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K930575 | Bova Intl. | KAMPPETER ANOMALOSCOPE | 1994-02-25 | 386 |
| K913962 | Lkc Technologies, Inc. | ANOMALOSCOPE QUADRANT TEST-6 | 1991-10-23 | 48 |
| K860174 | Chromagraphics, Inc. | GUNKEL CHROMAGRAPH COLOR VISION TESTER | 1986-04-04 | 77 |
Recalls for HIW devices
openFDA lists no recalls for product code HIW.
Frequently asked questions
What is FDA product code HIW?
HIW is the FDA product code for anomaloscope. It is a Class I device, regulated under 21 CFR 886.1070 and reviewed by the Ophthalmic panel.
What device class is HIW?
Class I, regulation 21 CFR 886.1070. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HIW?
Across 3 cleared submissions the average was 170 days from receipt to decision (median 77).
Which companies have the most HIW clearances?
Bova Intl. (1); Lkc Technologies, Inc. (1); Chromagraphics, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HIW
- Run a recall and safety report across every HIW manufacturer
- Watch product code HIW 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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