FDA product code KYT: Light, Examination, Medical, Battery Powered
KYT is the FDA product code for light, examination, medical, battery powered. It is a Class I device, regulated under 21 CFR 880.6350 and reviewed by the General Hospital panel. FDA has cleared 6 510(k) submissions under KYT, from 5 different applicants. The average 510(k) review took 44 days (median 35). FDA has posted 1 recall for KYT devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Light, Examination, Medical, Battery Powered |
| Device class | Class I |
| Regulation | 21 CFR 880.6350 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every KYT clearance
Top KYT applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Suncoast Medical Manufacturers, Inc. | 2 | 1984-05-22 |
| Olympic Medical Corp. | 1 | 1992-03-27 |
| Concept, Inc. | 1 | 1979-06-22 |
| Abco Dealers, Inc. | 1 | 1978-09-07 |
| Taylor Instrument Analytics Co. | 1 | 1977-01-26 |
Most recent KYT clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K920782 | Olympic Medical Corp. | OLYMPIC TRANS-LITE | 1992-03-27 | 36 |
| K841589 | Suncoast Medical Manufacturers, Inc. | C-LITE | 1984-05-22 | 34 |
| K841588 | Suncoast Medical Manufacturers, Inc. | SUN-LITE WHITE SPOT | 1984-05-22 | 34 |
| K791001 | Concept, Inc. | PENLIGHT/SWAB HOLDER | 1979-06-22 | 24 |
| K781228 | Abco Dealers, Inc. | PENLIGHTS | 1978-09-07 | 52 |
Recalls for KYT devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2023-03-20.
| Year | Recalls |
|---|---|
| 2023 | 1 |
Frequently asked questions
What is FDA product code KYT?
KYT is the FDA product code for light, examination, medical, battery powered. It is a Class I device, regulated under 21 CFR 880.6350 and reviewed by the General Hospital panel.
What device class is KYT?
Class I, regulation 21 CFR 880.6350. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KYT?
Across 6 cleared submissions the average was 44 days from receipt to decision (median 35).
Which companies have the most KYT clearances?
Suncoast Medical Manufacturers, Inc. (2); Olympic Medical Corp. (1); Concept, Inc. (1); Abco Dealers, Inc. (1); Taylor Instrument Analytics Co. (1).
Have KYT devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2023-03-20.
Next steps
- Run an FDA pathway report with predicate devices for product code KYT
- Run a recall and safety report across every KYT manufacturer
- Watch product code KYT 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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