Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Huntleigh Healthcare , Ltd. · Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
189 daysmedian FDA review time
265 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K250777 | Sonicaid Team3 | Huntleigh Healthcare , Ltd. | 2025-09-19 | 189 | 0 |
| K241368 | Sonicaid Team3 | Huntleigh Healthcare , Ltd. | 2025-02-03 | 265 | 0 |
| K211200 | WoundExpress | Huntleigh Healthcare , Ltd. | 2021-09-03 | 134 | 0 |
| K183574 | SRX Handheld Doppler, DMX Handheld Doppler, Obstetric Probes | Huntleigh Healthcare , Ltd. | 2019-09-06 | 259 | 0 |
| K152228 | Hydroven 12, Hydroven 12 Garments | Huntleigh Healthcare , Ltd. | 2016-04-04 | 241 | 0 |
| K090285 | SONICAID FM820 AND FM830 ENCORE | Huntleigh Healthcare , Ltd. | 2009-07-15 | 160 | 0 |
| K081572 | SMARTSIGNS MINPULSE | Huntleigh Healthcare , Ltd. | 2008-10-01 | 119 | 0 |
| K060230 | DOPPLEX CENTRALE | Huntleigh Healthcare , Ltd. | 2006-03-23 | 52 | 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