Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Karmelsonix — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K102229 | PULMOTRACK 2020 SYSTEM | Karmelsonix | 2011-03-04 | 207 | 0 |
| K101022 | PULMOTRACK 5050 WHOLTER, MODEL 5050 | Karmelsonix | 2010-07-09 | 87 | 0 |
| K090863 | PERSONAL WHEEZOMETER | Karmelsonix | 2009-09-21 | 175 | 0 |
| K071955 | WIM-PC, MODEL 1010 | Karmelsonix | 2007-11-01 | 108 | 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