FDA product code HOE: Caliper, Ophthalmic
HOE is the FDA product code for caliper, ophthalmic. It is a Class I device, regulated under 21 CFR 886.4350 and reviewed by the Ophthalmic panel. FDA has cleared 7 510(k) submissions under HOE, from 7 different applicants. The average 510(k) review took 40 days (median 35).
Classification
| Field | Value |
|---|---|
| Device name | Caliper, Ophthalmic |
| Device class | Class I |
| Regulation | 21 CFR 886.4350 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every HOE clearance
Top HOE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| CooperVision, Inc. | 1 | 1988-04-01 |
| Design Research Assoc., Inc. | 1 | 1982-03-01 |
| Accutome, Inc. | 1 | 1982-02-24 |
| Koi, Inc. | 1 | 1981-07-28 |
| Aztec Medical Products, Inc. | 1 | 1980-09-16 |
2 more applicants have HOE clearances. See the full list in Caduvo.
Most recent HOE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K881094 | CooperVision, Inc. | KOI(TM) BLADE GAUGE, MODEL KOI-132 | 1988-04-01 | 17 |
| K813315 | Design Research Assoc., Inc. | CALIPER-OPTHALMIC | 1982-03-01 | 97 |
| K820050 | Accutome, Inc. | KREMER BLADE GAUGE | 1982-02-24 | 47 |
| K812011 | Koi, Inc. | BLADE GAUGE | 1981-07-28 | 11 |
| K801937 | Aztec Medical Products, Inc. | BLEPHAROMETER | 1980-09-16 | 35 |
Recalls for HOE devices
openFDA lists no recalls for product code HOE.
Frequently asked questions
What is FDA product code HOE?
HOE is the FDA product code for caliper, ophthalmic. It is a Class I device, regulated under 21 CFR 886.4350 and reviewed by the Ophthalmic panel.
What device class is HOE?
Class I, regulation 21 CFR 886.4350. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HOE?
Across 7 cleared submissions the average was 40 days from receipt to decision (median 35).
Which companies have the most HOE clearances?
CooperVision, Inc. (1); Design Research Assoc., Inc. (1); Accutome, Inc. (1); Koi, Inc. (1); Aztec Medical Products, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HOE
- Run a recall and safety report across every HOE manufacturer
- Watch product code HOE 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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