Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Pdg Product Design Group, Inc. · Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
28 daysmedian FDA review time
283 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K163432 | Stellar LEAP | Pdg Product Design Group, Inc. | 2017-06-27 | 202 | 0 |
| K140023 | ELEVATION | Pdg Product Design Group, Inc. | 2014-10-16 | 283 | 0 |
| K063736 | FUZE MECHANICAL WHEELCHAIR, MODELS T20 AND T50 | Pdg Product Design Group, Inc. | 2007-01-17 | 30 | 1 |
| K061475 | ASTROTILT MANUAL WHEELCHAIR | Pdg Product Design Group, Inc. | 2006-06-14 | 15 | 0 |
| K990557 | THE STELLAR TILT, MANUALLY OPERATED WHEELCHAIR | Pdg Product Design Group, Inc. | 1999-03-22 | 28 | 0 |
| K971389 | ECLIPSE 400 MANUALLY OPERATED WHEELCAIR | Pdg Product Design Group, Inc. | 1997-05-09 | 25 | 0 |
| K970311 | BENTLEY MANUALLY OPERATED WHEELCHAIR | Pdg Product Design Group, Inc. | 1997-02-14 | 18 | 0 |
| K961743 | ECLIPSE 600 MANUALLY OPERATED WHEELCHAIR | Pdg Product Design Group, Inc. | 1996-05-29 | 26 | 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