Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Huntleigh Healthcare Limited · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K201425 | Disposable Intraoperative Probe (DIOP8) | Huntleigh Healthcare Limited | 2021-02-19 | 266 | 0 |
| K200975 | Sonicaid Team3 Antepartum, Sonicaid Team3 Intrapartum | Huntleigh Healthcare Limited | 2020-06-24 | 72 | 0 |
| K132650 | SONICAID FREEDOM WIRELESS FETAL MONITORING SYSTEM | Huntleigh Healthcare Limited | 2014-02-07 | 165 | 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