FDA product code HRM: Microscope, Operating & Accessories, Ac-Powered, Ophthalmic
HRM is the FDA product code for microscope, operating & accessories, ac-powered, ophthalmic. It is a Class I device, regulated under 21 CFR 878.4700 and reviewed by the General and Plastic Surgery panel. FDA has cleared 14 510(k) submissions under HRM, from 11 different applicants. The average 510(k) review took 75 days (median 42). FDA has posted 7 recalls for HRM devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Microscope, Operating & Accessories, Ac-Powered, Ophthalmic |
| Device class | Class I |
| Regulation | 21 CFR 878.4700 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every HRM clearance
Top HRM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Keeler Instruments, Inc. | 4 | 1992-02-03 |
| Hill-Med, Inc. | 1 | 1993-09-07 |
| Marco Ophthalmic, Inc. | 1 | 1993-07-22 |
| Alcon Laboratories | 1 | 1992-10-09 |
| Carl Zeiss, Inc. | 1 | 1989-06-08 |
6 more applicants have HRM clearances. See the full list in Caduvo.
Most recent HRM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K932720 | Hill-Med, Inc. | HM-0970 | 1993-09-07 | 95 |
| K930439 | Marco Ophthalmic, Inc. | MARCO SURGISCOPE OPERATION MICROSCOPES | 1993-07-22 | 177 |
| K920641 | Alcon Laboratories | ALCON OPERATING MICROSCOPES | 1992-10-09 | 240 |
| K914956 | Keeler Instruments, Inc. | KEELER KONAN SPECULAR MICROSCOPE SP5500 | 1992-02-03 | 90 |
| K891584 | Carl Zeiss, Inc. | S 22 INSTRUMENT STAND | 1989-06-08 | 80 |
Recalls for HRM devices
7 product recalls in 7 recall events; 1 initiated in the last five years and 2 still open. Most recent: 2022-11-21.
| Year | Recalls |
|---|---|
| 2017 | 2 |
| 2018 | 1 |
| 2019 | 1 |
| 2020 | 1 |
| 2022 | 1 |
Frequently asked questions
What is FDA product code HRM?
HRM is the FDA product code for microscope, operating & accessories, ac-powered, ophthalmic. It is a Class I device, regulated under 21 CFR 878.4700 and reviewed by the General and Plastic Surgery panel.
What device class is HRM?
Class I, regulation 21 CFR 878.4700. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HRM?
Across 14 cleared submissions the average was 75 days from receipt to decision (median 42).
Which companies have the most HRM clearances?
Keeler Instruments, Inc. (4); Hill-Med, Inc. (1); Marco Ophthalmic, Inc. (1); Alcon Laboratories (1); Carl Zeiss, Inc. (1).
Have HRM devices been recalled?
Yes: 7 product recalls across 7 recall events; the most recent began 2022-11-21.
Next steps
- Run an FDA pathway report with predicate devices for product code HRM
- Run a recall and safety report across every HRM manufacturer
- Watch product code HRM 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.
All General and Plastic Surgery product codes · FDA product code lookup · 510(k) database search · 510(k) review times