FDA product code KYG: Device, Irrigation, Ocular Surgery
KYG is the FDA product code for device, irrigation, ocular surgery. It is a Class I device, regulated under 21 CFR 886.4360 and reviewed by the Ophthalmic panel. FDA has cleared 40 510(k) submissions under KYG, from 31 different applicants. The average 510(k) review took 91 days (median 74). FDA has posted 11 recalls for KYG devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Device, Irrigation, Ocular Surgery |
| Device class | Class I |
| Regulation | 21 CFR 886.4360 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
Top KYG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Visitec Co. | 3 | 1992-03-19 |
| Med-Logics, Inc. | 2 | 2001-04-27 |
| Optical Micro Systems, Inc. | 2 | 1994-02-16 |
| Site Microsurgical Systems, Inc. | 2 | 1993-12-06 |
| B&B Medical Assoc., Inc. | 2 | 1988-08-22 |
26 more applicants have KYG clearances. See the full list in Caduvo.
Most recent KYG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K010353 | Med-Logics, Inc. | MED-LOGICS DISPOSABLE ALK TUBING | 2001-04-27 | 80 |
| K003036 | Retinalabs.Com | TURBO-FLOW INFUSION CANNULA 19 GAGE,20 GAGE,23 GAGE, 25 GAGE, MODEL 101019,101020,101023,101025 | 2000-12-22 | 84 |
| K993591 | Blade Works, Inc. | BLADEWORKS DISPOSABLE ALK TUBING | 1999-12-28 | 67 |
| K981116 | Allergan, Inc. | SOVEREIGN CATARACT EXTRACTION SYSTEM | 1998-05-19 | 53 |
| K980647 | Eye-Deal Ocular Safety Products, Inc. | EYE IRRIGATOR MODEL #2020 | 1998-05-15 | 87 |
Recalls for KYG devices
11 product recalls in 5 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2023-09-26.
| Year | Recalls |
|---|---|
| 2023 | 1 |
Frequently asked questions
What is FDA product code KYG?
KYG is the FDA product code for device, irrigation, ocular surgery. It is a Class I device, regulated under 21 CFR 886.4360 and reviewed by the Ophthalmic panel.
What device class is KYG?
Class I, regulation 21 CFR 886.4360. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KYG?
Across 40 cleared submissions the average was 91 days from receipt to decision (median 74).
Which companies have the most KYG clearances?
Visitec Co. (3); Med-Logics, Inc. (2); Optical Micro Systems, Inc. (2); Site Microsurgical Systems, Inc. (2); B&B Medical Assoc., Inc. (2).
Have KYG devices been recalled?
Yes: 11 product recalls across 5 recall events; the most recent began 2023-09-26.
Next steps
- Run an FDA pathway report with predicate devices for product code KYG
- Run a recall and safety report across every KYG manufacturer
- Watch product code KYG 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.