FDA product code KYB: Lens, Guide, Intraocular
KYB is the FDA product code for lens, guide, intraocular. It is a Class I device, regulated under 21 CFR 886.4300 and reviewed by the Ophthalmic panel. FDA has cleared 39 510(k) submissions under KYB, from 27 different applicants. The average 510(k) review took 126 days (median 87). FDA has posted 7 recalls for KYB devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Lens, Guide, Intraocular |
| Device class | Class I |
| Regulation | 21 CFR 886.4300 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every KYB clearance
Top KYB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Staar Surgical Co. | 6 | 2004-06-10 |
| Alcon Laboratories | 3 | 1998-07-09 |
| Duckworth & Kent, Ltd. | 2 | 2008-10-23 |
| Chiron Vision Corp. | 2 | 1995-06-02 |
| Allergan Medical Optics | 2 | 1994-07-06 |
22 more applicants have KYB clearances. See the full list in Caduvo.
Most recent KYB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K152357 | STAAR Surgical Company | MicroSTAAR Injector System Cartridges | 2015-10-30 | 71 |
| K081382 | Duckworth & Kent, Ltd. | DUCKWORTH & KENT, LTD., IMPLANTATION SYSTEM, MODEL DK7786 | 2008-10-23 | 160 |
| K072985 | Duckworth & Kent, Ltd. | DUCKWORTH & KENT LTD INJECTOR, MODEL: DK7797-2 | 2008-06-20 | 241 |
| K070669 | Medicel AG | IOL INJECTOR SET | 2007-11-01 | 234 |
| K063155 | Alcon Manufacturing, Ltd. | MONARCH III IOL DELIVERY SYSTEM | 2007-03-27 | 161 |
Recalls for KYB devices
7 product recalls in 7 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2024-11-13.
| Year | Recalls |
|---|---|
| 2024 | 1 |
Frequently asked questions
What is FDA product code KYB?
KYB is the FDA product code for lens, guide, intraocular. It is a Class I device, regulated under 21 CFR 886.4300 and reviewed by the Ophthalmic panel.
What device class is KYB?
Class I, regulation 21 CFR 886.4300. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KYB?
Across 39 cleared submissions the average was 126 days from receipt to decision (median 87).
Which companies have the most KYB clearances?
Staar Surgical Co. (6); Alcon Laboratories (3); Duckworth & Kent, Ltd. (2); Chiron Vision Corp. (2); Allergan Medical Optics (2).
Have KYB devices been recalled?
Yes: 7 product recalls across 7 recall events; the most recent began 2024-11-13.
Next steps
- Run an FDA pathway report with predicate devices for product code KYB
- Run a recall and safety report across every KYB manufacturer
- Watch product code KYB 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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