Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
SAH — Predicate Candidate Screening
8 FDA 510(k) clearances under this product code; the 50 most recent screened below.
122 daysmedian FDA review time
253 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253102 | GT Metabolic MagDI System (MAG-01, MAG-02, DS-01) | Gt Metabolic Solutions, Inc. | 2026-06-04 | 253 | 0 |
| K253550 | Self-Forming Magnet (Flexagon Plus OTOLoc) | GI Windows, Inc. | 2026-01-09 | 56 | 0 |
| K250541 | Self-Forming Magnet (Flexagon Plus OTOLoc) | GI Windows, Inc. | 2025-08-01 | 158 | 0 |
| K243482 | Self-Forming Magnet (Flexagon) | GI Windows, Inc. | 2025-06-11 | 215 | 0 |
| K243359 | MagDI System (MAG-02, DS-01) | Gt Metabolic Solutions, Inc. | 2025-02-28 | 122 | 0 |
| K243213 | Self-Forming Magnet (FLEX SFM) | GI Windows, Inc. | 2025-01-29 | 118 | 0 |
| K242086 | MagDI System (MAG-01, DS-01) | Gt Metabolic Solutions, Inc. | 2024-10-24 | 99 | 0 |
| DEN240013 | MagDI System | Gt Metabolic Solutions, Inc. | 2024-07-02 | 98 | 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