FDA product code KYD: Strip, Schirmer
KYD is the FDA product code for strip, schirmer. It is a Class I device, regulated under 21 CFR 886.1800 and reviewed by the Ophthalmic panel. FDA has cleared 3 510(k) submissions under KYD, from 3 different applicants. The average 510(k) review took 94 days (median 42).
Classification
| Field | Value |
|---|---|
| Device name | Strip, Schirmer |
| Device class | Class I |
| Regulation | 21 CFR 886.1800 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every KYD clearance
Top KYD applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Northland Cataract & Eye Care Clinic | 1 | 1991-11-07 |
| Visionex, Inc. | 1 | 1988-05-23 |
| Smith & Nephew, Inc. | 1 | 1983-08-12 |
Most recent KYD clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K911734 | Northland Cataract & Eye Care Clinic | TEARTEC RAPID LACRIMAL ASSESMENT SYSTEM | 1991-11-07 | 204 |
| K881515 | Visionex, Inc. | TEAR VOLUME TESTS | 1988-05-23 | 42 |
| K832181 | Smith & Nephew, Inc. | SNO STRIPS STERILE TEARFLOW TEST STRIP | 1983-08-12 | 37 |
Recalls for KYD devices
openFDA lists no recalls for product code KYD.
Frequently asked questions
What is FDA product code KYD?
KYD is the FDA product code for strip, schirmer. It is a Class I device, regulated under 21 CFR 886.1800 and reviewed by the Ophthalmic panel.
What device class is KYD?
Class I, regulation 21 CFR 886.1800. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KYD?
Across 3 cleared submissions the average was 94 days from receipt to decision (median 42).
Which companies have the most KYD clearances?
Northland Cataract & Eye Care Clinic (1); Visionex, Inc. (1); Smith & Nephew, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KYD
- Run a recall and safety report across every KYD manufacturer
- Watch product code KYD 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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