Firstkind Limited: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “Firstkind Limited” (first 2014, latest 2022), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 78 days. Since 2017 the median was 78 days, against 137 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 | 203 |
| 2015 | 1 | 35 |
| 2016 | 1 | 64 |
| 2017 | 1 | 153 |
| 2018 | 1 | 30 |
| 2019 | 1 | 145 |
| 2020 | 2 | 54 |
| 2021 | 1 | 90 |
| 2022 | 1 | 28 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Firstkind Limited took a median 78 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 137 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| IPF | Stimulator, Muscle, Powered | 9 | 9 |
| NGX | Stimulator, Muscle, Powered, For Muscle Conditioning | 2 | 2 |
Review panels
- Physical Medicine (11)
Most recent Firstkind Limited 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K220327 | geko W-3 | IPF | 2022-03-04 | 28 |
| K212762 | geko W-2 | IPF | 2021-11-29 | 90 |
| K201131 | firefly T-2 | NGX | 2020-05-28 | 30 |
| K193045 | geko W-2 | IPF | 2020-01-18 | 78 |
| K191113 | geko T-2 and geko T-3 Neuromuscular Stimulators | IPF | 2019-09-18 | 145 |
| K181059 | geko T-3 Neuromuscular Stimulator | IPF | 2018-05-23 | 30 |
| K163125 | geko T-2 and geko Plus R-2 Neuromuscular Stimulators | IPF | 2017-04-10 | 153 |
| K160299 | geko(TM) Plus R-2 Neuromuscular Stimulator | IPF | 2016-04-08 | 64 |
| K152677 | geko T-2 Neuromuscular Stimulator | IPF | 2015-10-23 | 35 |
| K133638 | GEKO | IPF | 2014-08-21 | 267 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Firstkind Limited.
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.
- Firstkind, Ltd. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Firstkind Limited?
FDA lists 11 510(k) clearances under the applicant name “Firstkind Limited” (first 2014, latest 2022), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Firstkind Limited?
The median time from FDA receipt to decision across 510(k)s cleared under the name Firstkind Limited is 78 days. Since 2017: 78 days, versus 137 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Firstkind Limited?
The most frequent FDA product codes under this applicant name are IPF (Stimulator, Muscle, Powered, 9); NGX (Stimulator, Muscle, Powered, For Muscle Conditioning, 2).
Next steps
- See all 11 Firstkind Limited clearances with predicates and recalls
- Run predicate analysis for product code IPF, Firstkind Limited'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.