Auxein Medical Private Limited: FDA clearances and approvals
Auxein Medical Private Limited has 12 FDA 510(k) clearances (first 2020, latest 2023), across 5 product codes in 1 review panel. Median 510(k) review time: 355 days. Since 2017 its median was 355 days, against 90 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2020 | 1 | 320 |
| 2021 | 2 | 242 |
| 2022 | 7 | 378 |
| 2023 | 2 | 510 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Auxein Medical Private Limited's cleared 510(k)s took a median 355 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 90 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HRS | Plate, Fixation, Bone | 4 | 4 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | 4 | 4 |
| HWC | Screw, Fixation, Bone | 2 | 2 |
| JDS | Nail, Fixation, Bone | 1 | 1 |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | 1 | 1 |
Review panels
- Orthopedic (12)
Most recent Auxein Medical Private Limited 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K221787 | Auxein's DHS/DCS Plate System | KTT | 2023-11-30 | 527 |
| K213059 | Tibia and Fibula System | HRS | 2023-01-27 | 492 |
| K213110 | AUXILOCK PEEK OPTIMA Screw-In Suture Anchor, AUXILOCK ROTADOR PEEK OPTIMA Screw-In Anchor | MBI | 2022-12-16 | 448 |
| K213018 | Auxilock GFS Mini, GFS II Large, and GFS Ultimate | MBI | 2022-11-18 | 424 |
| K213108 | Humerus & Ulna System | HRS | 2022-11-04 | 406 |
| K213014 | Varixis Elbow System | HRS | 2022-10-03 | 378 |
| K213109 | Auxilock Draw Tight Suture-Based Anchor | MBI | 2022-08-22 | 332 |
| K213104 | Auxilock Titanium Screw-In Suture Anchor | MBI | 2022-07-29 | 308 |
| K211324 | 2.4mm Distal Radius System | HRS | 2022-03-14 | 318 |
| K210792 | Auxein Nailing System | HWC | 2021-08-25 | 163 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Auxein Medical Private 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 Auxein Medical Private Limited have?
Auxein Medical Private Limited has 12 FDA 510(k) clearances (first 2020, latest 2023), across 5 product codes in 1 review panel.
How long does FDA take to clear Auxein Medical Private Limited's 510(k)s?
The median time from FDA receipt to decision across Auxein Medical Private Limited's cleared 510(k)s is 355 days. Since 2017: 355 days, versus 90 days for all cleared 510(k)s in the same product codes.
What devices does Auxein Medical Private Limited make?
Its most frequent FDA product codes are HRS (Plate, Fixation, Bone, 4); MBI (Fastener, Fixation, Nondegradable, Soft Tissue, 4); HWC (Screw, Fixation, Bone, 2).
Has Auxein Medical Private Limited had device recalls?
openFDA lists no recalls under a recalling firm name matching Auxein Medical Private Limited. Related entities may recall under other names.
Next steps
- See all 12 Auxein Medical Private Limited clearances with predicates and recalls
- Run predicate analysis for product code HRS, Auxein Medical Private 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.