Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Mon-A-Therm, Inc. · Predicate Candidate Screening
17 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
65 daysmedian FDA review time
101 days90th percentile
17clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K885187 | MODEL 1000 ELECTRONIC CLINICAL THERMOMETER | Mon-A-Therm, Inc. | 1989-03-08 | 84 | 0 |
| K874522 | MODIFIED MYOCARDIAL TEMPERATURE SENSOR | Mon-A-Therm, Inc. | 1988-01-29 | 88 | 0 |
| K874519 | MODIFIED ESOPHAGEAL STETHOSCOPE/TEMPERATURE SENSOR | Mon-A-Therm, Inc. | 1988-01-29 | 88 | 0 |
| K875234 | MON-A-THERM'S SKIN TEMPERATURE SENSOR | Mon-A-Therm, Inc. | 1988-01-19 | 28 | 0 |
| K874523 | MODIFIED TYMPANIC & ESOPHAGEAL/RECTAL TEMP. SENSOR | Mon-A-Therm, Inc. | 1988-01-06 | 65 | 0 |
| K874524 | MODIFIED SUBCUTANEOUS TEMPERATURE SENSOR | Mon-A-Therm, Inc. | 1988-01-06 | 65 | 0 |
| K874520 | MODIFIED AIRWAY TEMPERATURE SENSOR | Mon-A-Therm, Inc. | 1988-01-06 | 65 | 0 |
| K874521 | MODIFIED THERMAL WELL TEMPERATURE SENSOR | Mon-A-Therm, Inc. | 1988-01-06 | 65 | 0 |
| K874525 | MODIFIED FOLEY CATHETER/TEMPERATURE SENSOR | Mon-A-Therm, Inc. | 1988-01-06 | 65 | 0 |
| K853392 | MON-A-THERM SUBCUTANEOUS TEMP. SENSOR | Mon-A-Therm, Inc. | 1985-11-22 | 101 | 0 |
| K830819 | MODIFICATION ELECTRONIC CLINICAL THERMO- | Mon-A-Therm, Inc. | 1983-04-06 | 22 | 0 |
| K830470 | ANESTHESIA BREATHING CIRCUITS | Mon-A-Therm, Inc. | 1983-03-24 | 37 | 0 |
| K830552 | LUER LOCK TEMPERATURE SENSOR | Mon-A-Therm, Inc. | 1983-03-17 | 22 | 0 |
| K823333 | MODEL 400 & 700 TEMP. SENSOR ADAPTERS | Mon-A-Therm, Inc. | 1983-01-12 | 65 | 0 |
| K821505 | AIRWAY TEMPERATURE SENSOR | Mon-A-Therm, Inc. | 1982-12-09 | 203 | 0 |
| K821504 | THERMAL WELL TEMPERATURE SENSOR | Mon-A-Therm, Inc. | 1982-06-23 | 34 | 0 |
| K820426 | TEMPERATURE TREND INDICATOR (TTI) | Mon-A-Therm, Inc. | 1982-03-08 | 20 | 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