Huntleigh Healthcare, Inc.: FDA filings under this applicant name
FDA lists 24 510(k) clearances under the applicant name “Huntleigh Healthcare, Inc.” (first 1993, latest 2025), across 9 product codes in 4 review panels. Median 510(k) review time under this name: 182 days. Since 2017 the median was 224 days, against 121 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 1 | 266 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 1 | 241 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 1 | 259 |
| 2020 | 0 | — |
| 2021 | 1 | 134 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 2 | 227 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Huntleigh Healthcare, Inc. took a median 224 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 121 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HGM | System, Monitoring, Perinatal | 9 | 9 |
| JOW | Sleeve, Limb, Compressible | 7 | 7 |
| DPW | Flowmeter, Blood, Cardiovascular | 2 | 2 |
| DQA | Oximeter | 1 | 1 |
| DQK | Computer, Diagnostic, Programmable | 1 | 1 |
| ITX | Transducer, Ultrasonic, Diagnostic | 1 | 1 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 1 | 1 |
| JOM | Plethysmograph, Photoelectric, Pneumatic Or Hydraulic | 1 | 1 |
| KNG | Monitor, Ultrasonic, Fetal | 1 | 1 |
Review panels
- Cardiovascular (11)
- Obstetrics and Gynecology (10)
- Radiology (2)
- Anesthesiology (1)
Most recent Huntleigh Healthcare, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K250777 | Sonicaid Team3 | HGM | 2025-09-19 | 189 |
| K241368 | Sonicaid Team3 | HGM | 2025-02-03 | 265 |
| K211200 | WoundExpress | JOW | 2021-09-03 | 134 |
| K183574 | SRX Handheld Doppler, DMX Handheld Doppler, Obstetric Probes, Vascular Probes | DPW | 2019-09-06 | 259 |
| K152228 | Hydroven 12, Hydroven 12 Garments | JOW | 2016-04-04 | 241 |
| K121108 | DOPPLEX ABILITY | JOM | 2013-01-03 | 266 |
| K090285 | SONICAID FM820 AND FM830 ENCORE | HGM | 2009-07-15 | 160 |
| K081572 | SMARTSIGNS MINPULSE | DQA | 2008-10-01 | 119 |
| K060230 | DOPPLEX CENTRALE | HGM | 2006-03-23 | 52 |
| K053369 | MEDILOG DARWIN HOLTER ANALYSIS | DQK | 2005-12-22 | 17 |
14 earlier clearances. See the full list in Caduvo.
Recalls
1 product recalls in 1 recall events; 1 initiated in the last five years. Most recent: 2022-02-11.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Huntleigh Healthcare, Inc. is the lead sponsor of 1 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT05659394: Intermittent Pneumatic Compression of the Thigh (Completed, started 2023-01-25)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Huntleigh Technology, Inc. (23 510(k)s)
- Huntleigh Diagnostics , Ltd. (3 510(k)s)
- Huntleigh Healthcare Limited (3 510(k)s)
- Huntleigh Group , Ltd. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Huntleigh Healthcare, Inc.?
FDA lists 24 510(k) clearances under the applicant name “Huntleigh Healthcare, Inc.” (first 1993, latest 2025), across 9 product codes in 4 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Huntleigh Healthcare, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Huntleigh Healthcare, Inc. is 182 days. Since 2017: 224 days, versus 121 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Huntleigh Healthcare, Inc.?
The most frequent FDA product codes under this applicant name are HGM (System, Monitoring, Perinatal, 9); JOW (Sleeve, Limb, Compressible, 7); DPW (Flowmeter, Blood, Cardiovascular, 2).
Next steps
- See all 24 Huntleigh Healthcare, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HGM, Huntleigh Healthcare, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.