Guilin Woodpecker Medical Instrument Co., Ltd.: FDA filings under this applicant name
FDA lists 14 510(k) clearances under the applicant name “Guilin Woodpecker Medical Instrument Co., Ltd.” (first 2006, latest 2025), across 10 product codes in 2 review panels. Median 510(k) review time under this name: 205 days. Since 2017 the median was 214 days, against 172 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 |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 1 | 237 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 4 | 196 |
| 2022 | 5 | 391 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 1 | 118 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Guilin Woodpecker Medical Instrument Co., Ltd. took a median 214 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 172 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| EBW | Controller, Foot, Handpiece And Cord | 2 | 2 |
| EHD | Unit, X-Ray, Extraoral With Timer | 2 | 2 |
| EKX | Handpiece, Direct Drive, Ac-Powered | 2 | 2 |
| ELC | Scaler, Ultrasonic | 2 | 2 |
| DZI | Drill, Bone, Powered | 1 | 1 |
| EBZ | Activator, Ultraviolet, For Polymerization | 1 | 1 |
| EFB | Handpiece, Air-Powered, Dental | 1 | 1 |
| LQY | Locator, Root Apex | 1 | 1 |
| MUH | System, X-Ray, Extraoral Source, Digital | 1 | 1 |
| NVK | Laser, Dental, Soft Tissue | 1 | 1 |
Review panels
Most recent Guilin Woodpecker Medical Instrument Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K251438 | Dental X-Ray Device (Ai Ray Lite, Ai Ray Pro, Master Ray ) | EHD | 2025-09-04 | 118 |
| K222569 | Ai Ray Dental X-Ray Device | EHD | 2022-11-23 | 91 |
| K211358 | Implanter incl. Accessories | EBW | 2022-11-21 | 567 |
| K221548 | Dental Air Polishing Handpiece | EFB | 2022-09-28 | 124 |
| K210367 | D-Laser Blue, D-Laser 16 | NVK | 2022-03-10 | 395 |
| K203706 | Dental Electric Motor | EBW | 2022-01-13 | 391 |
| K211531 | Cordless Prophy System, Model: i-Polish | EKX | 2021-12-17 | 214 |
| K203615 | Dental Scaler and Air Polisher | ELC | 2021-12-10 | 365 |
| K212080 | Imaging Plate Scanner, i-Scan | MUH | 2021-09-27 | 87 |
| K203320 | Endo Motor | EKX | 2021-05-10 | 179 |
4 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Guilin Woodpecker Medical Instrument Co., Ltd..
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.
- Guilin Kevin Peter Technology Co., Ltd. (4 510(k)s)
- Guilin Refine Medical Instrument Co., Ltd. (3 510(k)s)
- Guilin Hbm Health Protections, Inc. (2 510(k)s)
- Guilin Aesthedent Medical Instruments Co., Ltd. (1 510(k)s)
- Guilin Fiteeth Medical Instrument Co., Ltd. (1 510(k)s)
- Guilin Fourth Latex Plant (1 510(k)s)
- Guilin Hbm Sanitary Protections, Inc. (1 510(k)s)
- Guilin Latex Factory (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Guilin Woodpecker Medical Instrument Co., Ltd.?
FDA lists 14 510(k) clearances under the applicant name “Guilin Woodpecker Medical Instrument Co., Ltd.” (first 2006, latest 2025), across 10 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 Guilin Woodpecker Medical Instrument Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Guilin Woodpecker Medical Instrument Co., Ltd. is 205 days. Since 2017: 214 days, versus 172 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Guilin Woodpecker Medical Instrument Co., Ltd.?
The most frequent FDA product codes under this applicant name are EBW (Controller, Foot, Handpiece And Cord, 2); EHD (Unit, X-Ray, Extraoral With Timer, 2); EKX (Handpiece, Direct Drive, Ac-Powered, 2).
Next steps
- See all 14 Guilin Woodpecker Medical Instrument Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code EBW, Guilin Woodpecker Medical Instrument Co., Ltd.'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.