Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Huntleigh Technology, Inc. — Predicate Candidate Screening
23 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
92 daysmedian FDA review time
259 days90th percentile
23clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K992733 | AKRON ATP9 TRACTION MACHINE | Huntleigh Technology, Inc. | 1999-11-10 | 89 | 0 |
| K964699 | RHEO DOPPLEX II (RD 2) | Huntleigh Technology, Inc. | 1997-02-21 | 88 | 0 |
| K924516 | OP3/VP4 | Huntleigh Technology, Inc. | 1993-06-28 | 297 | 0 |
| K910188 | FLOWPLUS AC330 PUMP GARMENTS | Huntleigh Technology, Inc. | 1991-05-28 | 132 | 0 |
| K900882 | MULTI DOPPLEX, MD-1 | Huntleigh Technology, Inc. | 1990-08-22 | 177 | 0 |
| K900618 | HUNTLEIGH FETAL DOPPLER, FD-1 & DOPCORD, D140 | Huntleigh Technology, Inc. | 1990-04-25 | 76 | 0 |
| K890012 | HUNTLEIGH DYNAMIC FLOTATION SYSTEM | Huntleigh Technology, Inc. | 1989-03-29 | 85 | 0 |
| K884451 | DOPCORD PPG | Huntleigh Technology, Inc. | 1989-01-12 | 80 | 0 |
| K881632 | FLOWTRON DVT SYSTEM AC500 PUMP, L501 GARMENT | Huntleigh Technology, Inc. | 1988-09-26 | 165 | 0 |
| K874688 | FLOWTRON AC200/2 | Huntleigh Technology, Inc. | 1988-09-23 | 315 | 0 |
| K882644 | HUNTLEIGH DOUBLE BUBBLE AIR-O-PAD-AOP5 | Huntleigh Technology, Inc. | 1988-08-10 | 44 | 0 |
| K871271 | HUNTLEIGH FLOWPRESS AC300 PUMP, SQ301/302/320 GAR. | Huntleigh Technology, Inc. | 1987-09-15 | 168 | 0 |
| K871272 | HUNTLEIGH FLOWPAC FP2000 | Huntleigh Technology, Inc. | 1987-06-25 | 86 | 0 |
| K870681 | HUNTLEIGH BETA II HM85 | Huntleigh Technology, Inc. | 1987-03-04 | 13 | 0 |
| K854267 | HUNTLEIGH DOPCORD, D140 | Huntleigh Technology, Inc. | 1986-07-09 | 259 | 0 |
| K850945 | HUNTLEIGH FLOWTRON AIR HAND GARMENT, HG300 | Huntleigh Technology, Inc. | 1985-08-20 | 166 | 0 |
| K850910 | HUNTLEIGH FLOWTRON AIR, AC400/2 AIR | Huntleigh Technology, Inc. | 1985-08-20 | 168 | 0 |
| K844879 | HUNTLEIGH ALPHACARE, HM95 ALTERNATING PRESS-PUMP | Huntleigh Technology, Inc. | 1985-01-25 | 39 | 0 |
| K844880 | HUNTLEIGH AIR-O-PAD AOP1 ALTERNATING PRESS-MATTRES | Huntleigh Technology, Inc. | 1985-01-25 | 39 | 0 |
| K834399 | NEW MOTHER'S WAY-BREAST PUMP | Huntleigh Technology, Inc. | 1984-01-17 | 34 | 0 |
| K823081 | M2100 ANTEPARTUM FETAL MONITOR | Huntleigh Technology, Inc. | 1983-01-26 | 99 | 0 |
| K823188 | M2000 INTRAPARTUM FETAL MONITOR | Huntleigh Technology, Inc. | 1983-01-26 | 92 | 0 |
| K810115 | DOPPLEX-PLB & PXB | Huntleigh Technology, Inc. | 1981-07-16 | 181 | 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