Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
KPD — Predicate Candidate Screening
21 FDA 510(k) clearances under this product code; the 50 most recent screened below.
43 daysmedian FDA review time
119 days90th percentile
21clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K934941 | E-Z TEMP II | Seven C'S, Inc. | 1994-07-27 | 282 | 0 |
| K903307 | TEMP MARQ TEMPERATURE TREND INDICATOR | Marquest Medical Products, Inc. | 1990-08-17 | 24 | 0 |
| K893803 | FEVER LINE AND FEVER LINE PLUS | Liquid Crystal Sciences, Inc. | 1989-08-21 | 91 | 0 |
| K864853 | OMNI THERM TEMPERATURE MONITOR | Omni Therm, Inc. | 1987-02-04 | 55 | 0 |
| K850797 | TEMPALERT LIQUID CRYSTAL THERMOMETER | Medical Frontiers, Inc. | 1985-04-05 | 37 | 0 |
| K841913 | TEMPTREND PEDS AXILLARY TEMP. INDICATOR | Biosynergy, Inc. | 1984-11-02 | 177 | 0 |
| K833904 | TEMPTREND II | Biosynergy, Inc. | 1983-12-27 | 43 | 0 |
| K832651 | ATI FOREHEAD THERMOMETER | American Thermal Instruments, Inc. | 1983-10-04 | 57 | 0 |
| K823221 | ACCA-TEMP SKIN TEMP. VINYL DISC | T. G. & E. Medical | 1983-01-12 | 75 | 0 |
| K821312 | TEMPTREND TEMPERATURE TREND INDICATOR | Liquid Crystal Products, Inc. | 1982-05-28 | 24 | 0 |
| K820426 | TEMPERATURE TREND INDICATOR (TTI) | Mon-A-Therm, Inc. | 1982-03-08 | 20 | 0 |
| K813199 | SKIN TEMPERATURE SENSING VINYL STRIP | T. G. & E. Medical | 1982-03-05 | 112 | 0 |
| K802778 | LIQUID CRYSTAL THERM. 8 EVENT MONITOR | Djinnii Industires, Inc. | 1981-01-09 | 65 | 0 |
| K802897 | ELECTRONIC DIGITAL THERMOMETER | Philip J. Teders | 1980-12-16 | 29 | 0 |
| K790532 | FEVER TESTER | Maddak, Inc. | 1979-05-29 | 75 | 0 |
| K780580 | TEMPERATURE INDICATOR | Respiratory Care, Inc. | 1978-04-27 | 17 | 0 |
| K780260 | TEMP. SENSOR W/22MM FITTINGS | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1978-03-14 | 27 | 0 |
| K771980 | FEVER TESTER | American Thermometer Company, Inc. | 1977-11-02 | 16 | 0 |
| K770517 | NF DEVICE | Rpr, Inc. | 1977-07-15 | 119 | 0 |
| K770353 | DISPOSABLE TEMPERATURE PROBE | Inhal-O-Tech Medical Plastic | 1977-03-16 | 22 | 0 |
| K760683 | ALARM, THERMAL, THERM-ALERT | Respiratory Care, Inc. | 1976-09-27 | 7 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda