FDA product code HME: Chair, Ophthalmic, Ac-Powered
HME is the FDA product code for chair, ophthalmic, ac-powered. It is a Class I device, regulated under 21 CFR 886.1140 and reviewed by the Ophthalmic panel. FDA has cleared 16 510(k) submissions under HME, from 13 different applicants. The average 510(k) review took 67 days (median 38). FDA has posted 1 recall for HME devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Chair, Ophthalmic, Ac-Powered |
| Device class | Class I |
| Regulation | 21 CFR 886.1140 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every HME clearance
Top HME applicants
| Applicant | Clearances | Latest |
|---|---|---|
| F. & F. Koenigkramer | 3 | 1985-09-05 |
| Koken Mfg Company, Inc. | 2 | 1986-12-15 |
| Marco Ophthalmic, Inc. | 1 | 1993-07-06 |
| Icor AB | 1 | 1992-06-23 |
| Reliance Medical Products, Inc. | 1 | 1989-09-12 |
8 more applicants have HME clearances. See the full list in Caduvo.
Most recent HME clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K930449 | Marco Ophthalmic, Inc. | MARCO, MARCOTILT, ENCORE AND CUSTOM CHAIR | 1993-07-06 | 161 |
| K914416 | Icor AB | BREATH-EASY, MODIFICATION | 1992-06-23 | 272 |
| K894018 | Reliance Medical Products, Inc. | RELIANCE(R) 6200 EXAMINATION CHAIR | 1989-09-12 | 98 |
| K870112 | Storz Instrument Co. | STORZ ENT/OPHTHALMIC MAXI CHAIR | 1987-02-12 | 31 |
| K864494 | Koken Mfg Company, Inc. | MODEL 6500 OPTHALMIC CHAIR | 1986-12-15 | 31 |
Recalls for HME devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2023-05-31.
| Year | Recalls |
|---|---|
| 2023 | 1 |
Frequently asked questions
What is FDA product code HME?
HME is the FDA product code for chair, ophthalmic, ac-powered. It is a Class I device, regulated under 21 CFR 886.1140 and reviewed by the Ophthalmic panel.
What device class is HME?
Class I, regulation 21 CFR 886.1140. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HME?
Across 16 cleared submissions the average was 67 days from receipt to decision (median 38).
Which companies have the most HME clearances?
F. & F. Koenigkramer (3); Koken Mfg Company, Inc. (2); Marco Ophthalmic, Inc. (1); Icor AB (1); Reliance Medical Products, Inc. (1).
Have HME devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2023-05-31.
Next steps
- Run an FDA pathway report with predicate devices for product code HME
- Run a recall and safety report across every HME manufacturer
- Watch product code HME 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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