Skylark Device & Systems Co., Ltd.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Skylark Device & Systems Co., Ltd.” (first 2000, latest 2005), across 6 product codes in 3 review panels. Median 510(k) review time under this name: 206 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 |
|---|---|---|---|
| GYB | Media, Electroconductive | 1 | 1 |
| GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief | 1 | 1 |
| ILY | Lamp, Infrared, Therapeutic Heating | 1 | 1 |
| IPF | Stimulator, Muscle, Powered | 1 | 1 |
| KPI | Stimulator, Electrical, Non-Implantable, For Incontinence | 1 | 1 |
| LIH | Interferential Current Therapy | 1 | 1 |
Review panels
Most recent Skylark Device & Systems Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K053007 | SKYLARK URO PROBE | KPI | 2005-12-05 | 40 |
| K050174 | BIO-STIM KIT | GZJ | 2005-09-07 | 225 |
| K043306 | SKYLARK INFRARED PHOTON STIMULATOR, MODELS, SD-956IR AND SD-100IR | ILY | 2005-06-06 | 187 |
| K034005 | SDS-4I | IPF | 2004-11-18 | 330 |
| K002832 | CONDUCTIVE GEL FOR ULTRASOUND | GYB | 2001-08-06 | 329 |
| K992652 | SD-730 IF-SDS, PERFECT PULSE IF-SDS | LIH | 2000-02-03 | 181 |
Recalls
openFDA lists no recalls under a recalling firm named Skylark Device & Systems 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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Skylark Device & Systems Co., Ltd. (a text match, not an official crosswalk):
- L8678 — Electrical stimulator supplies (external) for use with implantable neurostimulator, per month (via KPI)
- C1767 — Generator, neurostimulator (implantable), non-rechargeable (via KPI)
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 Co., Ltd. (20 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Skylark Device & Systems Co., Ltd.?
FDA lists 6 510(k) clearances under the applicant name “Skylark Device & Systems Co., Ltd.” (first 2000, latest 2005), across 6 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 & Systems Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Skylark Device & Systems Co., Ltd. is 206 days.
Which FDA product codes appear under Skylark Device & Systems Co., Ltd.?
The most frequent FDA product codes under this applicant name are GYB (Media, Electroconductive, 1); GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief, 1); ILY (Lamp, Infrared, Therapeutic Heating, 1).
Next steps
- See all 6 Skylark Device & Systems Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code GYB, Skylark Device & Systems 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.