Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Huntleigh Healthcare, Inc. · Predicate Candidate Screening
14 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
286 daysmedian FDA review time
479 days90th percentile
14clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K032315 | IOP8 INTRA OPERATIVE PROBE | Huntleigh Healthcare, Inc. | 2004-11-18 | 479 | 0 |
| K022786 | DVT60 | Huntleigh Healthcare, Inc. | 2002-09-19 | 28 | 0 |
| K010744 | FLOWTRON UNIVERSAL, MODEL AC600 | Huntleigh Healthcare, Inc. | 2002-03-26 | 378 | 1 |
| K012008 | STS RANGE , MODELS STS20,STS30,STS40 | Huntleigh Healthcare, Inc. | 2001-09-21 | 86 | 0 |
| K002186 | VASCULAR ASSIST | Huntleigh Healthcare, Inc. | 2001-05-02 | 286 | 1 |
| K010889 | BABY DOPPLEX 3000 MK 2 (BD3000) | Huntleigh Healthcare, Inc. | 2001-04-25 | 30 | 0 |
| K010894 | BABY DOPPLEX 3002 (BD3002) | Huntleigh Healthcare, Inc. | 2001-04-25 | 30 | 0 |
| K001882 | BABY DOPPLEX 4002-TWINS, MODEL BD4002 | Huntleigh Healthcare, Inc. | 2000-09-19 | 90 | 0 |
| K990569 | BABY DOPPLEX 4000, MODEL BD 4000 | Huntleigh Healthcare, Inc. | 2000-01-24 | 335 | 0 |
| K984307 | MODIFICATION OF: RHEO DOPPLEX II | Huntleigh Healthcare, Inc. | 1999-01-12 | 41 | 0 |
| K965153 | HUNTLEIGH FP5000 SYSTEM MODEL FP5000 | Huntleigh Healthcare, Inc. | 1998-01-26 | 399 | 0 |
| K963711 | BABY DOPPLEX (3000) | Huntleigh Healthcare, Inc. | 1997-09-12 | 361 | 0 |
| K930200 | MULTI DOPPLEX II / FETAL DOPPLEX II | Huntleigh Healthcare, Inc. | 1994-06-24 | 526 | 0 |
| K925717 | CALF GARMENT DVT10(S) COMPRESSIBLE LIMB SLEEVE | Huntleigh Healthcare, Inc. | 1993-05-07 | 176 | 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