FDA product code HOO: Perimeter, Ac-Powered
HOO is the FDA product code for perimeter, ac-powered. It is a Class I device, regulated under 21 CFR 886.1605 and reviewed by the Ophthalmic panel. FDA has cleared 6 510(k) submissions under HOO, from 6 different applicants. The average 510(k) review took 61 days (median 44).
Classification
| Field | Value |
|---|---|
| Device name | Perimeter, Ac-Powered |
| Device class | Class I |
| Regulation | 21 CFR 886.1605 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every HOO clearance
Top HOO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Welch Allyn, Inc. | 1 | 1994-06-06 |
| Marco Ophthalmic, Inc. | 1 | 1993-06-21 |
| Richmond Products, Inc. | 1 | 1987-11-02 |
| Keeler Instruments, Inc. | 1 | 1986-12-15 |
| Bio-Rad | 1 | 1986-02-27 |
1 more applicants have HOO clearances. See the full list in Caduvo.
Most recent HOO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K941723 | Welch Allyn, Inc. | WELCH ALLYN GLAUCOMA DETECTOR | 1994-06-06 | 60 |
| K930448 | Marco Ophthalmic, Inc. | MARCO PROJECTION PERIMETER | 1993-06-21 | 146 |
| K873912 | Richmond Products, Inc. | RICHMOND VISUAL FIELD SCREENER | 1987-11-02 | 38 |
| K864467 | Keeler Instruments, Inc. | HENSON - HAMBLIN CFS 2000 CENTRAL FIELD SCREEN | 1986-12-15 | 33 |
| K860115 | Bio-Rad | DIGILAB CAMBRIDGE PERIMETER | 1986-02-27 | 45 |
Recalls for HOO devices
openFDA lists no recalls for product code HOO.
Frequently asked questions
What is FDA product code HOO?
HOO is the FDA product code for perimeter, ac-powered. It is a Class I device, regulated under 21 CFR 886.1605 and reviewed by the Ophthalmic panel.
What device class is HOO?
Class I, regulation 21 CFR 886.1605. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HOO?
Across 6 cleared submissions the average was 61 days from receipt to decision (median 44).
Which companies have the most HOO clearances?
Welch Allyn, Inc. (1); Marco Ophthalmic, Inc. (1); Richmond Products, Inc. (1); Keeler Instruments, Inc. (1); Bio-Rad (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HOO
- Run a recall and safety report across every HOO manufacturer
- Watch product code HOO 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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