Skylark Device Co., Ltd.: FDA filings under this applicant name
FDA lists 20 510(k) clearances under the applicant name “Skylark Device Co., Ltd.” (first 1991, latest 1999), across 9 product codes in 3 review panels. Median 510(k) review time under this name: 202 days. 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 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief | 10 | 10 |
| IPF | Stimulator, Muscle, Powered | 2 | 2 |
| LIH | Interferential Current Therapy | 2 | 2 |
| EGJ | Device, Iontophoresis, Other Uses | 1 | 1 |
| FLL | Continuous Measurement Thermometer | 1 | 1 |
| GXY | Electrode, Cutaneous | 1 | 1 |
| GYB | Media, Electroconductive | 1 | 1 |
| ILY | Lamp, Infrared, Therapeutic Heating | 1 | 1 |
| IMI | Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat | 1 | 1 |
Review panels
- Neurology (14)
- Physical Medicine (5)
- General Hospital (1)
Most recent Skylark Device Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K990233 | ST-302 INFRAREX | ILY | 1999-10-27 | 275 |
| K984506 | SD-100 SKYEAR THERMOMETER | FLL | 1999-07-29 | 223 |
| K981449 | SD-956 ULTRASOUND THERAPY | IMI | 1998-12-11 | 233 |
| K983964 | BATCH #6060 CONDUCTIVE GEL | GYB | 1998-12-09 | 33 |
| K964437 | GB-1002 TENS WITH MASSAGE | GZJ | 1998-08-14 | 647 |
| K974585 | IF-727 INTERFERENTIAL STIMULATOR | LIH | 1998-03-06 | 88 |
| K964434 | SD-970EMS ELECTRICAL MUSCULAR STIMULATOR | IPF | 1997-10-09 | 338 |
| K963729 | SD-610M(ALSO KNOWN AS STANDARD TENS, SD-609M,SD-611M, GLC-I STANDARD) | GZJ | 1997-02-13 | 150 |
| K946337 | IT-727 (ALSO KNOWN AS IT-610, IT-600 AND DYNAPHOR II | EGJ | 1995-12-20 | 356 |
| K946299 | PGS123 AND HVS-123 | GZJ | 1995-06-26 | 181 |
10 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Skylark Device 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.
- Skylark Device & Systems Co., Ltd. (6 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Skylark Device Co., Ltd.?
FDA lists 20 510(k) clearances under the applicant name “Skylark Device Co., Ltd.” (first 1991, latest 1999), across 9 product codes in 3 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 Skylark Device Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Skylark Device Co., Ltd. is 202 days.
Which FDA product codes appear under Skylark Device Co., Ltd.?
The most frequent FDA product codes under this applicant name are GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief, 10); IPF (Stimulator, Muscle, Powered, 2); LIH (Interferential Current Therapy, 2).
Next steps
- See all 20 Skylark Device Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code GZJ, Skylark Device 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.