Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Guardian Products Co., Inc. · Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
28 daysmedian FDA review time
61 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K915108 | FOLDING WHEELCHAIR | Guardian Products Co., Inc. | 1992-01-13 | 61 | 0 |
| K842649 | BATH TUB TRANSFER CHAIR | Guardian Products Co., Inc. | 1984-08-10 | 31 | 0 |
| K842650 | WALL GRAB BARS 98130-98136 | Guardian Products Co., Inc. | 1984-08-10 | 31 | 0 |
| K842651 | COMMODE CHAIR 98200 | Guardian Products Co., Inc. | 1984-08-07 | 28 | 0 |
| K821009 | BATHTUB GRAB BAR | Guardian Products Co., Inc. | 1982-04-21 | 9 | 0 |
| K821010 | BATHTUB TRANSFER BENCH | Guardian Products Co., Inc. | 1982-04-21 | 9 | 0 |
| K790299 | FOREARM-CANE | Guardian Products Co., Inc. | 1979-02-21 | 9 | 0 |
| K772049 | WALKING AID | Guardian Products Co., Inc. | 1977-11-11 | 11 | 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