Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Thompson Respiration Products, Inc. · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
160 daysmedian FDA review time
166 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K822103 | MODEL M3000XA VENTILATOR SPECIFICA | Thompson Respiration Products, Inc. | 1982-07-26 | 10 | 0 |
| K782174 | PRESSURE ALARM | Thompson Respiration Products, Inc. | 1979-01-22 | 34 | 0 |
| K781158 | ALARM UNIT, BATTERY OPERATED | Thompson Respiration Products, Inc. | 1978-12-18 | 166 | 0 |
| K781160 | VENTILATOR, MINILUNG | Thompson Respiration Products, Inc. | 1978-12-13 | 161 | 0 |
| K781159 | VENTILATOR, PRESSURE | Thompson Respiration Products, Inc. | 1978-12-12 | 160 | 0 |
| K781161 | RESPIRATOR, BANTAM MODEL | Thompson Respiration Products, Inc. | 1978-12-11 | 159 | 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