Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Sibel Health, Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
125 daysmedian FDA review time
241 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253021 | ANNE Maternal | Sibel Health, Inc. | 2026-02-26 | 160 | 0 |
| K242842 | ANNE View, Central Hub | Sibel Health, Inc. | 2025-01-08 | 111 | 0 |
| K240251 | ANNE Chest | Sibel Health, Inc. | 2024-06-03 | 125 | 0 |
| K240305 | ANNE Limb | Sibel Health, Inc. | 2024-05-28 | 116 | 0 |
| K223711 | ANNE One | Sibel Health, Inc. | 2023-08-10 | 241 | 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