Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Tactile Systems Technology, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
53 daysmedian FDA review time
293 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K143185 | entré Model PD08-U | Tactile Systems Technology, Inc. | 2015-05-07 | 183 | 0 |
| K131193 | ACTITOUCH ACT-ADAPTIVE COMPRESSION THERAPY SYSTEM | Tactile Systems Technology, Inc. | 2013-06-18 | 53 | 0 |
| K120972 | FLEXITOUCH SYSTEM | Tactile Systems Technology, Inc. | 2012-04-13 | 11 | 0 |
| K062818 | FLEXITOUCH SYSTEM | Tactile Systems Technology, Inc. | 2006-10-06 | 16 | 0 |
| K013061 | BIOTOUCH MASSAGE THERAPY SYSTEM | Tactile Systems Technology, Inc. | 2002-07-01 | 293 | 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