Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
PNV — Predicate Candidate Screening
4 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K221024 | tremoflo C2 Airwave Oscillometry System | Thorasys Thoracic Medical Systems, Inc. | 2023-06-20 | 440 | 0 |
| K191876 | PulmoScan | Cognita Labs, LLC | 2020-03-18 | 247 | 0 |
| K170185 | tremoFlo C-100 Airwave Oscillometry System | Thorasys Thoracic Medical Systems, Inc. | 2017-09-12 | 232 | 0 |
| K152585 | Resmon PRO FULL | Medical Graphics Corp. | 2016-06-24 | 288 | 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