Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Allwin Medical Devices, Inc. · Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
255 daysmedian FDA review time
414 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K220781 | ARMADA Ureteral Dilator Set, ARMADA Nottingham One Step Dila | Allwin Medical Devices, Inc. | 2023-05-05 | 414 | 0 |
| K220730 | allFlex Ureteral Catheters, Krait Ureteral Catheters | Allwin Medical Devices, Inc. | 2022-10-13 | 213 | 0 |
| K203626 | SureStrip Vitrification Straw, SureLock Vitrification Straw | Allwin Medical Devices, Inc. | 2021-06-04 | 175 | 0 |
| K200248 | Allwin Embryo Transfer Catheters (ETC), Allwin ETC Stylets a | Allwin Medical Devices, Inc. | 2020-07-01 | 152 | 0 |
| K190659 | Ureteral Stent Open Tip/Closed Tip/Intraoperative Tip, Urete | Allwin Medical Devices, Inc. | 2019-12-02 | 263 | 0 |
| K190590 | Allwin Ovum Pickup Needles (ACE Single Lumen Ovum Pickup Nee | Allwin Medical Devices, Inc. | 2019-11-25 | 263 | 0 |
| K190522 | Allwin Intra Uterine Insemination Catheters (INSEMINA and IN | Allwin Medical Devices, Inc. | 2019-11-14 | 255 | 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