FDA product code KPD: Strip, Temperature, Forehead, Liquid Crystal
KPD is the FDA product code for strip, temperature, forehead, liquid crystal. It is a Class II device, regulated under 21 CFR 880.2200 and reviewed by the General Hospital panel. FDA has cleared 21 510(k) submissions under KPD, from 18 different applicants. The average 510(k) review took 65 days (median 43).
Classification
| Field | Value |
|---|---|
| Device name | Strip, Temperature, Forehead, Liquid Crystal |
| Device class | Class II |
| Regulation | 21 CFR 880.2200 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every KPD clearance
Top KPD applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Biosynergy, Inc. | 2 | 1984-11-02 |
| T. G. & E. Medical | 2 | 1983-01-12 |
| Respiratory Care, Inc. | 2 | 1978-04-27 |
| Seven C'S, Inc. | 1 | 1994-07-27 |
| Marquest Medical Products, Inc. | 1 | 1990-08-17 |
13 more applicants have KPD clearances. See the full list in Caduvo.
Most recent KPD clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K934941 | Seven C'S, Inc. | E-Z TEMP II | 1994-07-27 | 282 |
| K903307 | Marquest Medical Products, Inc. | TEMP MARQ TEMPERATURE TREND INDICATOR | 1990-08-17 | 24 |
| K893803 | Liquid Crystal Sciences, Inc. | FEVER LINE AND FEVER LINE PLUS | 1989-08-21 | 91 |
| K864853 | Omni Therm, Inc. | OMNI THERM TEMPERATURE MONITOR | 1987-02-04 | 55 |
| K850797 | Medical Frontiers, Inc. | TEMPALERT LIQUID CRYSTAL THERMOMETER | 1985-04-05 | 37 |
Recalls for KPD devices
openFDA lists no recalls for product code KPD.
Frequently asked questions
What is FDA product code KPD?
KPD is the FDA product code for strip, temperature, forehead, liquid crystal. It is a Class II device, regulated under 21 CFR 880.2200 and reviewed by the General Hospital panel.
What device class is KPD?
Class II, regulation 21 CFR 880.2200. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KPD?
Across 21 cleared submissions the average was 65 days from receipt to decision (median 43).
Which companies have the most KPD clearances?
Biosynergy, Inc. (2); T. G. & E. Medical (2); Respiratory Care, Inc. (2); Seven C'S, Inc. (1); Marquest Medical Products, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KPD
- Run a recall and safety report across every KPD manufacturer
- Watch product code KPD 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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