Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Theradapt Products, Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
159 daysmedian FDA review time
161 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K942397 | THERADAPT HIGHCHAIR/STROLLER INSERT | Theradapt Products, Inc. | 1994-06-22 | 34 | 0 |
| K926028 | BENCHES | Theradapt Products, Inc. | 1993-03-24 | 161 | 0 |
| K930520 | THERADAPT(R) ADJUSTABLE CLASSROOM CHAIR | Theradapt Products, Inc. | 1993-03-24 | 50 | 0 |
| K926026 | DESKS | Theradapt Products, Inc. | 1993-03-24 | 161 | 0 |
| K926025 | CHAIRS | Theradapt Products, Inc. | 1993-03-22 | 159 | 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