Huntleigh Technology, Inc.: FDA clearances and approvals
Huntleigh Technology, Inc. has 23 FDA 510(k) clearances (first 1981, latest 1999), across 13 product codes in 5 review panels. Median 510(k) review time: 92 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FNM | Mattress, Air Flotation, Alternating Pressure | 5 | 5 |
| KNG | Monitor, Ultrasonic, Fetal | 3 | 3 |
| DRM | Compressor, Cardiac, External | 2 | 2 |
| HGM | System, Monitoring, Perinatal | 2 | 2 |
| JOW | Sleeve, Limb, Compressible | 2 | 2 |
| HGL | Transducer, Ultrasonic, Obstetric | 1 | 1 |
| HGY | Pump, Breast, Non-Powered | 1 | 1 |
| IRP | Massager, Powered Inflatable Tube | 1 | 1 |
| ITH | Equipment, Traction, Powered | 1 | 1 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 1 | 1 |
Plus 3 more product codes.
Review panels
- Obstetrics and Gynecology (7)
- Cardiovascular (5)
- General Hospital (5)
- Physical Medicine (2)
- Radiology (2)
Most recent Huntleigh Technology, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K992733 | AKRON ATP9 TRACTION MACHINE | ITH | 1999-11-10 | 89 |
| K964699 | RHEO DOPPLEX II (RD 2) | IYN | 1997-02-21 | 88 |
| K924516 | OP3/VP4 | HGL | 1993-06-28 | 297 |
| K910188 | FLOWPLUS AC330 PUMP GARMENTS | JOW | 1991-05-28 | 132 |
| K900882 | MULTI DOPPLEX, MD-1 | JAF | 1990-08-22 | 177 |
| K900618 | HUNTLEIGH FETAL DOPPLER, FD-1 & DOPCORD, D140 | KNG | 1990-04-25 | 76 |
| K890012 | HUNTLEIGH DYNAMIC FLOTATION SYSTEM | FNM | 1989-03-29 | 85 |
| K884451 | DOPCORD PPG | JOM | 1989-01-12 | 80 |
| K881632 | FLOWTRON DVT SYSTEM AC500 PUMP, L501 GARMENT | JOW | 1988-09-26 | 165 |
| K874688 | FLOWTRON AC200/2 | IRP | 1988-09-23 | 315 |
13 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Huntleigh Technology, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Huntleigh Technology, Inc. have?
Huntleigh Technology, Inc. has 23 FDA 510(k) clearances (first 1981, latest 1999), across 13 product codes in 5 review panels.
How long does FDA take to clear Huntleigh Technology, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Huntleigh Technology, Inc.'s cleared 510(k)s is 92 days.
What devices does Huntleigh Technology, Inc. make?
Its most frequent FDA product codes are FNM (Mattress, Air Flotation, Alternating Pressure, 5); KNG (Monitor, Ultrasonic, Fetal, 3); DRM (Compressor, Cardiac, External, 2).
Has Huntleigh Technology, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Huntleigh Technology, Inc. Related entities may recall under other names.
Next steps
- See all 23 Huntleigh Technology, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FNM, Huntleigh Technology, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.