Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Quickie Designs, Inc. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
244 daysmedian FDA review time
580 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K972230 | QUICKIE P90 SERIES | Quickie Designs, Inc. | 1997-12-02 | 172 | 0 |
| K963385 | QUICKIE POWER WHEELCHAIRS P200 SERIES | Quickie Designs, Inc. | 1997-04-28 | 244 | 0 |
| K963382 | QUICKIE P100 SERIES | Quickie Designs, Inc. | 1997-04-28 | 244 | 0 |
| K963381 | QUICKIE P300 SERIES | Quickie Designs, Inc. | 1997-04-28 | 244 | 0 |
| K924278 | QUICKIE P200 | Quickie Designs, Inc. | 1994-03-28 | 580 | 0 |
| K900330 | QUICKIE P300 WHEELCHAIR | Quickie Designs, Inc. | 1990-02-15 | 23 | 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