Allwin Medical Devices, Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Allwin Medical Devices, Inc.” (first 2019, latest 2023), across 6 product codes in 2 review panels. Median 510(k) review time under this name: 255 days. Since 2017 the median was 255 days, against 224 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 |
|---|---|---|
| 2019 | 3 | 263 |
| 2020 | 1 | 152 |
| 2021 | 1 | 175 |
| 2022 | 1 | 213 |
| 2023 | 1 | 414 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Allwin Medical Devices, Inc. took a median 255 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 224 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MQF | Catheter, Assisted Reproduction | 2 | 2 |
| EZN | Dilator, Catheter, Ureteral | 1 | 1 |
| FAD | Stent, Ureteral | 1 | 1 |
| KOD | Catheter, Urological | 1 | 1 |
| MQE | Needle, Assisted Reproduction | 1 | 1 |
| MQK | Labware, Assisted Reproduction | 1 | 1 |
Review panels
Most recent Allwin Medical Devices, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K220781 | ARMADA Ureteral Dilator Set, ARMADA Nottingham One Step Dilator, ARMADA Amplatz Renal Dilator Sets, ARMADA Renal Dilator, Glider Amplatz Sheath, ARMADA Renal Dilator with Amplatz Sheath, Fascial Dilator Set, Introducer Sheath, Introducer Catheter | EZN | 2023-05-05 | 414 |
| K220730 | allFlex Ureteral Catheters, Krait Ureteral Catheters | KOD | 2022-10-13 | 213 |
| K203626 | SureStrip Vitrification Straw, SureLock Vitrification Straw | MQK | 2021-06-04 | 175 |
| K200248 | Allwin Embryo Transfer Catheters (ETC), Allwin ETC Stylets and Soft Obturators | MQF | 2020-07-01 | 152 |
| K190659 | Ureteral Stent Open Tip/Closed Tip/Intraoperative Tip, Ureteral Stent via Ureterorenoscope Open Tip/Closed Tip, Pediatric Ureteral Stent Open Tip/Closed Tip, Mono J Urinary Diversion Ureteral Stent Open Tip/Closed Tip, Multiloop Ureteral Stent Open Tip/Closed Tip | FAD | 2019-12-02 | 263 |
| K190590 | Allwin Ovum Pickup Needles (ACE Single Lumen Ovum Pickup Needle, OVUMPICK Double Lumen Ovum Pickup Needle, ACE-FL Single Lumen Ovum Pickup Needle with Flushing Line, ACE-M Manual Single Lumen Ovum Pickup Needle) | MQE | 2019-11-25 | 263 |
| K190522 | Allwin Intra Uterine Insemination Catheters (INSEMINA and INSEMINA Open Tip Intra Uterine Insemination Catheter, CURVED and CURVED Open Tip Intra Uterine Insemination Catheter, TRACKABLE and TRACKABLE Open Tip Intra Uterine Insemination Catheter, FLEXI and FLEXI Open Tip Intra Uterine Insemination Catheter, STUMPY Intra Uterine Insemination Catheter) | MQF | 2019-11-14 | 255 |
Recalls
openFDA lists no recalls under a recalling firm named Allwin Medical Devices, Inc..
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Allwin Medical Devices, Inc.?
FDA lists 7 510(k) clearances under the applicant name “Allwin Medical Devices, Inc.” (first 2019, latest 2023), across 6 product codes in 2 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 Allwin Medical Devices, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Allwin Medical Devices, Inc. is 255 days. Since 2017: 255 days, versus 224 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Allwin Medical Devices, Inc.?
The most frequent FDA product codes under this applicant name are MQF (Catheter, Assisted Reproduction, 2); EZN (Dilator, Catheter, Ureteral, 1); FAD (Stent, Ureteral, 1).
Next steps
- See all 7 Allwin Medical Devices, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MQF, Allwin Medical Devices, 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.