Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Thermoplastic Comfort Systems, Inc. · 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) |
|---|---|---|---|---|---|
| K142894 | TCS Blend | Thermoplastic Comfort Systems, Inc. | 2015-02-03 | 123 | 0 |
| K123396 | I.FLEX BY TCS | Thermoplastic Comfort Systems, Inc. | 2013-01-10 | 66 | 0 |
| K053060 | TCS UNBREAKABLE | Thermoplastic Comfort Systems, Inc. | 2006-07-20 | 262 | 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