FDA product code HLR: Keratoscope, Battery-Powered
HLR is the FDA product code for keratoscope, battery-powered. It is a Class I device, regulated under 21 CFR 886.1350 and reviewed by the Ophthalmic panel. FDA has cleared 7 510(k) submissions under HLR, from 7 different applicants. The average 510(k) review took 47 days (median 33).
Classification
| Field | Value |
|---|---|
| Device name | Keratoscope, Battery-Powered |
| Device class | Class I |
| Regulation | 21 CFR 886.1350 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every HLR clearance
Top HLR applicants
| Applicant | Clearances | Latest |
|---|---|---|
| The Sanborn Co. | 1 | 1990-07-20 |
| Technitex, Inc. | 1 | 1988-08-04 |
| Gamut Ent. | 1 | 1988-07-13 |
| Jedmed Instrument Co. | 1 | 1986-12-29 |
| Cutler Medical Instruments | 1 | 1985-12-27 |
2 more applicants have HLR clearances. See the full list in Caduvo.
Most recent HLR clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K901553 | The Sanborn Co. | SURG-K SURGICAL KERATOMETER | 1990-07-20 | 108 |
| K882902 | Technitex, Inc. | QRK 100, QUALITATIVE RING KERATOSCOPE | 1988-08-04 | 23 |
| K882618 | Gamut Ent. | JEDMED/POLACK KERATOSCOPE HS/SL | 1988-07-13 | 19 |
| K864639 | Jedmed Instrument Co. | REUSABLE SURGICAL KERATOSCOPE | 1986-12-29 | 33 |
| K854054 | Cutler Medical Instruments | PLACIDO DISC | 1985-12-27 | 85 |
Recalls for HLR devices
openFDA lists no recalls for product code HLR.
Frequently asked questions
What is FDA product code HLR?
HLR is the FDA product code for keratoscope, battery-powered. It is a Class I device, regulated under 21 CFR 886.1350 and reviewed by the Ophthalmic panel.
What device class is HLR?
Class I, regulation 21 CFR 886.1350. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HLR?
Across 7 cleared submissions the average was 47 days from receipt to decision (median 33).
Which companies have the most HLR clearances?
The Sanborn Co. (1); Technitex, Inc. (1); Gamut Ent. (1); Jedmed Instrument Co. (1); Cutler Medical Instruments (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HLR
- Run a recall and safety report across every HLR manufacturer
- Watch product code HLR 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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