Allengers Medical Systems Limited: FDA clearances and approvals
Allengers Medical Systems Limited has 8 FDA 510(k) clearances (first 2017, latest 2026), across 4 product codes in 1 review panel. Median 510(k) review time: 112 days. Since 2017 its median was 112 days, against 60 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2017 | 1 | 175 |
| 2018 | 0 | — |
| 2019 | 1 | 30 |
| 2020 | 1 | 167 |
| 2021 | 0 | — |
| 2022 | 3 | 59 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 1 | 135 |
| 2026 | 1 | 249 |
Review time against the same product codes
Since 2017, Allengers Medical Systems Limited's cleared 510(k)s took a median 112 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 60 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KPR | System, X-Ray, Stationary | 3 | 3 |
| MQB | Solid State X-Ray Imager (Flat Panel/Digital Imager) | 2 | 2 |
| OWB | Interventional Fluoroscopic X-Ray System | 2 | 2 |
| OXO | Image-Intensified Fluoroscopic X-Ray System, Mobile | 1 | 1 |
Review panels
- Radiology (8)
Most recent Allengers Medical Systems Limited 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K253296 | Digital C-ARM with 3D | OXO | 2026-06-05 | 249 |
| K243734 | Wireless/ Wired X-Ray Flat Panel Detectors | MQB | 2025-04-18 | 135 |
| K223009 | Wireless/Wired X-Ray Flat Panel Detectors | MQB | 2022-11-27 | 59 |
| K223060 | DigiX FDX | KPR | 2022-10-26 | 26 |
| K220311 | Cardiovascular Angiography System | OWB | 2022-05-03 | 90 |
| K200218 | Digiscan FDX | OWB | 2020-07-13 | 167 |
| K192541 | DigiX FDX | KPR | 2019-10-16 | 30 |
| K162529 | DigiX FDX | KPR | 2017-03-03 | 175 |
Recalls
openFDA lists no recalls under a recalling firm named Allengers Medical Systems Limited.
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 Allengers Medical Systems Limited have?
Allengers Medical Systems Limited has 8 FDA 510(k) clearances (first 2017, latest 2026), across 4 product codes in 1 review panel.
How long does FDA take to clear Allengers Medical Systems Limited's 510(k)s?
The median time from FDA receipt to decision across Allengers Medical Systems Limited's cleared 510(k)s is 112 days. Since 2017: 112 days, versus 60 days for all cleared 510(k)s in the same product codes.
What devices does Allengers Medical Systems Limited make?
Its most frequent FDA product codes are KPR (System, X-Ray, Stationary, 3); MQB (Solid State X-Ray Imager (Flat Panel/Digital Imager), 2); OWB (Interventional Fluoroscopic X-Ray System, 2).
Has Allengers Medical Systems Limited had device recalls?
openFDA lists no recalls under a recalling firm name matching Allengers Medical Systems Limited. Related entities may recall under other names.
Next steps
- See all 8 Allengers Medical Systems Limited clearances with predicates and recalls
- Run predicate analysis for product code KPR, Allengers Medical Systems Limited'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.