Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Gri-Alleset, 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) |
|---|---|---|---|---|---|
| K242664 | gentleheelĀ® Adult Incision Device | Gri-Alleset, Inc. | 2024-11-05 | 62 | 0 |
| K220917 | gentleheel Micro-Preemie, gentleheel Preemie, gentleheel New | Gri-Alleset, Inc. | 2022-05-18 | 49 | 0 |
| K210860 | Comfort Guard Mask, level 1, Comfort Guard Mask, level 3 | Gri-Alleset, Inc. | 2022-04-07 | 380 | 0 |
| K210131 | ComfortGuard Surgical Isolation Gown | Gri-Alleset, Inc. | 2021-08-26 | 219 | 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