Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Design Technologies, Inc. — 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) |
|---|---|---|---|---|---|
| K872038 | NEB-U-VENT | Design Technologies, Inc. | 1987-08-10 | 75 | 0 |
| K872358 | STA-PUT | Design Technologies, Inc. | 1987-08-06 | 49 | 0 |
| K871262 | MODIFIED NOFLO I | Design Technologies, Inc. | 1987-07-21 | 112 | 0 |
| K863613 | NO-FLO I | Design Technologies, Inc. | 1986-12-15 | 90 | 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