Mon-A-Therm, Inc.: FDA filings under this applicant name
FDA lists 17 510(k) clearances under the applicant name “Mon-A-Therm, Inc.” (first 1982, latest 1989), across 7 product codes in 5 review panels. Median 510(k) review time under this name: 65 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FLL | Continuous Measurement Thermometer | 11 | 11 |
| BZW | Stethoscope, Esophageal | 1 | 1 |
| CAI | Circuit, Breathing (W Connector, Adaptor, Y Piece) | 1 | 1 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 1 | 1 |
| KOD | Catheter, Urological | 1 | 1 |
| KPD | Strip, Temperature, Forehead, Liquid Crystal | 1 | 1 |
| KRB | Probe, Thermodilution | 1 | 1 |
Review panels
- General Hospital (12)
- Anesthesiology (2)
- Cardiovascular (1)
- Gastroenterology and Urology (1)
- General and Plastic Surgery (1)
Most recent Mon-A-Therm, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K885187 | MODEL 1000 ELECTRONIC CLINICAL THERMOMETER | FLL | 1989-03-08 | 84 |
| K874522 | MODIFIED MYOCARDIAL TEMPERATURE SENSOR | KRB | 1988-01-29 | 88 |
| K874519 | MODIFIED ESOPHAGEAL STETHOSCOPE/TEMPERATURE SENSOR | BZW | 1988-01-29 | 88 |
| K875234 | MON-A-THERM'S SKIN TEMPERATURE SENSOR | FLL | 1988-01-19 | 28 |
| K874525 | MODIFIED FOLEY CATHETER/TEMPERATURE SENSOR | KOD | 1988-01-06 | 65 |
| K874524 | MODIFIED SUBCUTANEOUS TEMPERATURE SENSOR | FLL | 1988-01-06 | 65 |
| K874523 | MODIFIED TYMPANIC & ESOPHAGEAL/RECTAL TEMP. SENSOR | FLL | 1988-01-06 | 65 |
| K874521 | MODIFIED THERMAL WELL TEMPERATURE SENSOR | FLL | 1988-01-06 | 65 |
| K874520 | MODIFIED AIRWAY TEMPERATURE SENSOR | FLL | 1988-01-06 | 65 |
| K853392 | MON-A-THERM SUBCUTANEOUS TEMP. SENSOR | FLL | 1985-11-22 | 101 |
7 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Mon-A-Therm, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Mon-A-Therm, Inc.?
FDA lists 17 510(k) clearances under the applicant name “Mon-A-Therm, Inc.” (first 1982, latest 1989), across 7 product codes in 5 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Mon-A-Therm, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Mon-A-Therm, Inc. is 65 days.
Which FDA product codes appear under Mon-A-Therm, Inc.?
The most frequent FDA product codes under this applicant name are FLL (Continuous Measurement Thermometer, 11); BZW (Stethoscope, Esophageal, 1); CAI (Circuit, Breathing (W Connector, Adaptor, Y Piece), 1).
Next steps
- See all 17 Mon-A-Therm, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FLL, Mon-A-Therm, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.