FDA product code KYA: System, Thermographic, Liquid Crystal, Nonpowered (Adjunctive Use)
KYA is the FDA product code for system, thermographic, liquid crystal, nonpowered (adjunctive use). It is a Class I device, regulated under 21 CFR 884.2982 and reviewed by the Radiology panel. FDA has cleared 5 510(k) submissions under KYA, from 4 different applicants. The average 510(k) review took 120 days (median 110).
Classification
| Field | Value |
|---|---|
| Device name | System, Thermographic, Liquid Crystal, Nonpowered (Adjunctive Use) |
| Device class | Class I |
| Regulation | 21 CFR 884.2982 |
| Review panel | RA — Radiology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every KYA clearance
Top KYA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| American Thermometer Company, Inc. | 2 | 1982-11-16 |
| Promedex, Inc. | 1 | 1990-12-07 |
| Bcsi Laboratories, Inc. | 1 | 1984-01-17 |
| Dr. John D. Reid B.A., D.C. | 1 | 1982-09-08 |
Most recent KYA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K900404 | Promedex, Inc. | VARICOSCREEN(TM) | 1990-12-07 | 312 |
| K832989 | Bcsi Laboratories, Inc. | BREAST THERMAL ACTIVITY INDICATOR | 1984-01-17 | 138 |
| K823245 | American Thermometer Company, Inc. | THERMAX; THERMAX SYSTEM | 1982-11-16 | 15 |
| K821524 | Dr. John D. Reid B.A., D.C. | CHIROPRATIC INFRA-RED CRYSTAL PAK | 1982-09-08 | 110 |
| K821049 | American Thermometer Company, Inc. | PARATHERM | 1982-04-29 | 23 |
Recalls for KYA devices
openFDA lists no recalls for product code KYA.
Frequently asked questions
What is FDA product code KYA?
KYA is the FDA product code for system, thermographic, liquid crystal, nonpowered (adjunctive use). It is a Class I device, regulated under 21 CFR 884.2982 and reviewed by the Radiology panel.
What device class is KYA?
Class I, regulation 21 CFR 884.2982. Typical premarket route: 510(k).
How long does a 510(k) take for product code KYA?
Across 5 cleared submissions the average was 120 days from receipt to decision (median 110).
Which companies have the most KYA clearances?
American Thermometer Company, Inc. (2); Promedex, Inc. (1); Bcsi Laboratories, Inc. (1); Dr. John D. Reid B.A., D.C. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KYA
- Run a recall and safety report across every KYA manufacturer
- Watch product code KYA 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.
All Radiology product codes · FDA product code lookup · 510(k) database search · 510(k) review times