FDA product code EYN: Tray, Irrigation, Sterile
EYN is the FDA product code for tray, irrigation, sterile. It is a Class II device, regulated under 21 CFR 876.5980 and reviewed by the General and Plastic Surgery panel. FDA has cleared 15 510(k) submissions under EYN, from 11 different applicants. The average 510(k) review took 141 days (median 94). FDA has posted 3 recalls for EYN devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Tray, Irrigation, Sterile |
| Device class | Class II |
| Regulation | 21 CFR 876.5980 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Top EYN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| American Healthcare Corp. | 4 | 1993-06-17 |
| Orion Life Systems, Inc. | 2 | 1990-04-19 |
| Clinical Resources, Inc. | 1 | 1995-01-12 |
| Kit Pak, Inc. | 1 | 1990-04-23 |
| The Healthcare Group Laboratories, Inc. | 1 | 1980-08-13 |
6 more applicants have EYN clearances. See the full list in Caduvo.
Most recent EYN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K944882 | Clinical Resources, Inc. | IRRIGATION TRAY | 1995-01-12 | 101 |
| K923939 | American Healthcare Corp. | IRRIGATION TRAY W/ BULB SYRINGE & STERILE WATER | 1993-06-17 | 316 |
| K923938 | American Healthcare Corp. | IRRIGATION TRAY W/ PISTON SYRINGE & STERILE WATER | 1993-06-17 | 316 |
| K923941 | American Healthcare Corp. | IRRIGATION TRAY W/ BULB SYRINGE & STERILE SALINE | 1993-06-17 | 316 |
| K923940 | American Healthcare Corp. | IRRIGATION TRAY W/ PISTON SYRINGE & STERILE SALINE | 1993-06-17 | 316 |
Recalls for EYN devices
3 product recalls in 3 recall events; 1 initiated in the last five years and 2 still open. Most recent: 2024-04-08.
| Year | Recalls |
|---|---|
| 2019 | 1 |
| 2024 | 1 |
Frequently asked questions
What is FDA product code EYN?
EYN is the FDA product code for tray, irrigation, sterile. It is a Class II device, regulated under 21 CFR 876.5980 and reviewed by the General and Plastic Surgery panel.
What device class is EYN?
Class II, regulation 21 CFR 876.5980. Typical premarket route: 510(k).
How long does a 510(k) take for product code EYN?
Across 15 cleared submissions the average was 141 days from receipt to decision (median 94).
Which companies have the most EYN clearances?
American Healthcare Corp. (4); Orion Life Systems, Inc. (2); Clinical Resources, Inc. (1); Kit Pak, Inc. (1); The Healthcare Group Laboratories, Inc. (1).
Have EYN devices been recalled?
Yes: 3 product recalls across 3 recall events; the most recent began 2024-04-08.
Next steps
- Run an FDA pathway report with predicate devices for product code EYN
- Run a recall and safety report across every EYN manufacturer
- Watch product code EYN 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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