Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Tactile Medical · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253555 | Flexitouch® Plus Advanced Pneumatic Compression System | Tactile Medical | 2026-07-31 | 259 | 0 |
| K252849 | AffloVest® Mobile Airway Clearance Therapy | Tactile Medical | 2026-04-30 | 234 | 0 |
| K234155 | Nimbl (model PD08-N1) | Tactile Medical | 2024-06-21 | 175 | 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