Nakanishi, Inc.: FDA clearances and approvals
Nakanishi, Inc. has 40 FDA 510(k) clearances (first 2001, latest 2026), across 10 product codes in 3 review panels. Median 510(k) review time: 186 days. Since 2017 its median was 168 days, against 239 days for all cleared 510(k)s in the same product codes. openFDA lists 11 product recalls by a recalling firm named Nakanishi, Inc.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 4 | 244 |
| 2013 | 5 | 244 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 4 | 230 |
| 2018 | 1 | 179 |
| 2019 | 1 | 168 |
| 2020 | 1 | 27 |
| 2021 | 2 | 268 |
| 2022 | 2 | 315 |
| 2023 | 2 | 97 |
| 2024 | 4 | 238 |
| 2025 | 3 | 28 |
| 2026 | 1 | 1 |
Review time against the same product codes
Since 2017, Nakanishi, Inc.'s cleared 510(k)s took a median 168 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 239 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| EFB | Handpiece, Air-Powered, Dental | 10 | 10 |
| EBW | Controller, Foot, Handpiece And Cord | 7 | 7 |
| ELC | Scaler, Ultrasonic | 7 | 7 |
| EGS | Handpiece, Contra- And Right-Angle Attachment, Dental | 5 | 5 |
| DZI | Drill, Bone, Powered | 2 | 2 |
| EKX | Handpiece, Direct Drive, Ac-Powered | 2 | 2 |
| HBC | Motor, Drill, Electric | 2 | 2 |
| HBE | Drills, Burrs, Trephines & Accessories (Simple, Powered) | 2 | 2 |
| KMW | Handpiece, Rotary Bone Cutting | 2 | 2 |
| ERL | Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | 1 | 1 |
Review panels
- Dental (35)
- Neurology (4)
- Ear, Nose and Throat (1)
Most recent Nakanishi, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K260773 | Varios Combi Pro2 | ELC | 2026-03-10 | 1 |
| K254163 | VarioSurg 4 | DZI | 2025-12-23 | 1 |
| K252662 | UniBur | HBE | 2025-09-19 | 28 |
| K251689 | VARIOS 170 LUX SCALER SYSTEM (VA170LUXS10); VARIOS 170 LUX SCALER SYSTEM (VA170LUXS11); VARIOS 170 SCALER SYSTEM (VA170S11) | ELC | 2025-09-19 | 109 |
| K241880 | Air Powered Tooth Polishing System (Perio-Mate); Air Powered Tooth Polishing System (Perio Mate Nozzle Tip) | EFB | 2024-09-20 | 84 |
| K233288 | NLZ Built-In Motor System | EBW | 2024-06-24 | 269 |
| K233117 | Surgic Pro2 (Surgic Pro2 OPT), Surgic Pro2 (Surgic Pro2 NON-OPT) | EBW | 2024-06-20 | 267 |
| K233308 | Air Motor (Model name: FX204 M4); Air Motor (Model name: M205) | EFB | 2024-04-25 | 209 |
| K230888 | Titanium Turbine | EFB | 2023-06-02 | 63 |
| K230106 | General Cutting Straight | EGS | 2023-05-24 | 131 |
30 earlier clearances. See the full list in Caduvo.
Recalls
11 product recalls in 2 recall events; 0 initiated in the last five years. Most recent: 2018-06-01.
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 Nakanishi, Inc. have?
Nakanishi, Inc. has 40 FDA 510(k) clearances (first 2001, latest 2026), across 10 product codes in 3 review panels.
How long does FDA take to clear Nakanishi, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Nakanishi, Inc.'s cleared 510(k)s is 186 days. Since 2017: 168 days, versus 239 days for all cleared 510(k)s in the same product codes.
What devices does Nakanishi, Inc. make?
Its most frequent FDA product codes are EFB (Handpiece, Air-Powered, Dental, 10); EBW (Controller, Foot, Handpiece And Cord, 7); ELC (Scaler, Ultrasonic, 7).
Has Nakanishi, Inc. had device recalls?
openFDA lists 11 product recalls in 2 recall events by a recalling firm whose name matches Nakanishi, Inc; the most recent began 2018-06-01. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 40 Nakanishi, Inc. clearances with predicates and recalls
- Run predicate analysis for product code EFB, Nakanishi, Inc.'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.