Nvision Biomedical Technologies, Inc.: FDA filings under this applicant name
FDA lists 39 510(k) clearances under the applicant name “Nvision Biomedical Technologies, Inc.” (first 2014, latest 2026), across 11 product codes in 2 review panels. Median 510(k) review time under this name: 74 days. Since 2017 the median was 68 days, against 90 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 |
|---|---|---|
| 2014 | 2 | 100 |
| 2015 | 0 | — |
| 2016 | 2 | 61 |
| 2017 | 2 | 42 |
| 2018 | 2 | 49 |
| 2019 | 4 | 100 |
| 2020 | 7 | 29 |
| 2021 | 3 | 180 |
| 2022 | 3 | 44 |
| 2023 | 2 | 277 |
| 2024 | 4 | 130 |
| 2025 | 5 | 54 |
| 2026 | 3 | 88 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Nvision Biomedical Technologies, Inc. took a median 68 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 |
|---|---|---|---|
| HWC | Screw, Fixation, Bone | 8 | 8 |
| PLF | Bone Wedge | 7 | 7 |
| HRS | Plate, Fixation, Bone | 6 | 6 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 5 | 5 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 4 | 4 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 3 | 3 |
| HTY | Pin, Fixation, Smooth | 2 | 2 |
| ETN | Stimulator, Nerve | 1 | 1 |
| JDR | Staple, Fixation, Bone | 1 | 1 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | 1 | 1 |
Plus 1 more product codes.
Review panels
- Orthopedic (38)
- Ear, Nose and Throat (1)
Most recent Nvision Biomedical Technologies, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K262098 | EnHAnce PEEK Bunion System | HRS | 2026-09-18 | 88 |
| K253718 | enHAnce PEEK Bunion System | HRS | 2026-04-01 | 128 |
| K260291 | Vortex5 Tailor's Bunion Correction System | HRS | 2026-03-25 | 55 |
| K253423 | ToeJack MIS Bunion System | HRS | 2025-11-18 | 54 |
| K252657 | Impact PEEK Union Nail System | HTY | 2025-09-19 | 28 |
| K250646 | Impact PEEK Union Nail System | HTY | 2025-06-11 | 99 |
| K250613 | SnapHammer Hammertoe Correction System | HWC | 2025-04-02 | 33 |
| K242896 | Caliber Intramedullary Fixation System | HWC | 2025-02-05 | 135 |
| K243231 | Trigon PEEK HA Wedges | PLF | 2024-11-08 | 30 |
| K240250 | 3D Printed PEEK Interbody System | MAX | 2024-09-17 | 231 |
29 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Nvision Biomedical Technologies, 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.
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.
- Nvision Medical Corporation (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Nvision Biomedical Technologies, Inc.?
FDA lists 39 510(k) clearances under the applicant name “Nvision Biomedical Technologies, Inc.” (first 2014, latest 2026), across 11 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 Nvision Biomedical Technologies, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Nvision Biomedical Technologies, Inc. is 74 days. Since 2017: 68 days, versus 90 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Nvision Biomedical Technologies, Inc.?
The most frequent FDA product codes under this applicant name are HWC (Screw, Fixation, Bone, 8); PLF (Bone Wedge, 7); HRS (Plate, Fixation, Bone, 6).
Next steps
- See all 39 Nvision Biomedical Technologies, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HWC, Nvision Biomedical Technologies, 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.