FDA product code HMX: Cannula, Ophthalmic
HMX is the FDA product code for cannula, ophthalmic. It is a Class I device, regulated under 21 CFR 886.4350 and reviewed by the Ophthalmic panel. FDA has cleared 77 510(k) submissions under HMX, from 35 different applicants. The average 510(k) review took 91 days (median 90). FDA has posted 28 recalls for HMX devices, 3 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Cannula, 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 HMX clearance
Top HMX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Advanced Surgical Products, Inc. | 29 | 1988-04-13 |
| Microsurgical Technology, Inc. | 6 | 1994-08-17 |
| Look, Inc. | 5 | 1987-08-10 |
| Visitec Co. | 3 | 1991-02-26 |
| Storz Instrument Co. | 2 | 1988-08-04 |
30 more applicants have HMX clearances. See the full list in Caduvo.
Most recent HMX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K010305 | Micron Surgical, Inc. | WEISS RETINAL CANNULA | 2001-05-02 | 90 |
| K000457 | Retinalabs.Com | VERTEFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 11000 SERIES; PHOTOFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 12000 SERIES | 2000-05-09 | 88 |
| K970873 | American Medical Devices, Inc. | ENDOSOFT SOFT TIP NEEDLE (20 GA. AND 19 GA.) | 1997-05-20 | 71 |
| K943932 | Pharma-Plast, Ltd. | STERISEAL OPHTHALMIC CANNULA | 1995-01-18 | 159 |
| K942403 | Microsurgical Technology, Inc. | INFUSION CANNULA | 1994-08-17 | 90 |
Recalls for HMX devices
28 product recalls in 18 recall events; 3 initiated in the last five years and 3 still open. Most recent: 2025-09-06.
| Year | Recalls |
|---|---|
| 2018 | 2 |
| 2019 | 6 |
| 2021 | 2 |
| 2022 | 1 |
| 2024 | 1 |
| 2025 | 1 |
Frequently asked questions
What is FDA product code HMX?
HMX is the FDA product code for cannula, ophthalmic. It is a Class I device, regulated under 21 CFR 886.4350 and reviewed by the Ophthalmic panel.
What device class is HMX?
Class I, regulation 21 CFR 886.4350. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HMX?
Across 77 cleared submissions the average was 91 days from receipt to decision (median 90).
Which companies have the most HMX clearances?
Advanced Surgical Products, Inc. (29); Microsurgical Technology, Inc. (6); Look, Inc. (5); Visitec Co. (3); Storz Instrument Co. (2).
Have HMX devices been recalled?
Yes: 28 product recalls across 18 recall events; the most recent began 2025-09-06.
Next steps
- Run an FDA pathway report with predicate devices for product code HMX
- Run a recall and safety report across every HMX manufacturer
- Watch product code HMX 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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