FDA product code HND: Spatula, Ophthalmic
HND is the FDA product code for spatula, ophthalmic. It is a Class I device, regulated under 21 CFR 886.4350 and reviewed by the Ophthalmic panel. FDA has cleared 6 510(k) submissions under HND, from 3 different applicants. The average 510(k) review took 21 days (median 22).
Classification
| Field | Value |
|---|---|
| Device name | Spatula, 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 HND clearance
Top HND applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Edward Weck, Inc. | 4 | 1980-08-13 |
| Keeler Instruments, Inc. | 1 | 1986-10-31 |
| American V. Mueller | 1 | 1981-05-15 |
Most recent HND clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K863990 | Keeler Instruments, Inc. | THORNTON TITANIUM SILVER SPATULA | 1986-10-31 | 17 |
| K810937 | American V. Mueller | ANIS IRRIGATING SPATULA | 1981-05-15 | 38 |
| K801609 | Edward Weck, Inc. | MADDOX LENS SPATULA CAT. #7245 | 1980-08-13 | 29 |
| K801608 | Edward Weck, Inc. | MCCULLEY CONTINUOUS SUTURE TIGHTNER | 1980-08-12 | 28 |
| K791983 | Edward Weck, Inc. | SPATULA'S #'S 7618,7248,7240,7242,5108 | 1979-10-04 | 9 |
Recalls for HND devices
openFDA lists no recalls for product code HND.
Frequently asked questions
What is FDA product code HND?
HND is the FDA product code for spatula, ophthalmic. It is a Class I device, regulated under 21 CFR 886.4350 and reviewed by the Ophthalmic panel.
What device class is HND?
Class I, regulation 21 CFR 886.4350. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HND?
Across 6 cleared submissions the average was 21 days from receipt to decision (median 22).
Which companies have the most HND clearances?
Edward Weck, Inc. (4); Keeler Instruments, Inc. (1); American V. Mueller (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HND
- Run a recall and safety report across every HND manufacturer
- Watch product code HND 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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