Kingston Technologies, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Kingston Technologies, Inc.” (first 1988, latest 1994), across 5 product codes in 3 review panels. Median 510(k) review time under this name: 120 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 |
|---|---|---|---|
| KMF | Bandage, Liquid | 2 | 2 |
| DQX | Wire, Guide, Catheter | 1 | 1 |
| FAD | Stent, Ureteral | 1 | 1 |
| MGP | Dressing, Wound And Burn, Occlusive | 1 | 1 |
| MGQ | Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic | 1 | 1 |
Review panels
Most recent Kingston Technologies, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K935232 | HYDROTORQUE GUIDE WIRE | DQX | 1994-07-20 | 261 |
| K940814 | HYDRO-M(TM) WOUND GEL | MGQ | 1994-05-12 | 79 |
| K940738 | KTI HY-Q(TM) WOUND DRESSING | KMF | 1994-05-06 | 78 |
| K925660 | KTI TRANSPARENT WOUND DRESSING | MGP | 1993-04-20 | 161 |
| K921502 | HYSORB WOUND DRESSING | KMF | 1992-09-29 | 182 |
| K882157 | PANAMEX(TM) URETERAL STENT | FAD | 1988-08-02 | 71 |
Recalls
openFDA lists no recalls under a recalling firm named Kingston Technologies, Inc..
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Kingston Technologies, Inc.?
FDA lists 6 510(k) clearances under the applicant name “Kingston Technologies, Inc.” (first 1988, latest 1994), across 5 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 Kingston Technologies, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Kingston Technologies, Inc. is 120 days.
Which FDA product codes appear under Kingston Technologies, Inc.?
The most frequent FDA product codes under this applicant name are KMF (Bandage, Liquid, 2); DQX (Wire, Guide, Catheter, 1); FAD (Stent, Ureteral, 1).
Next steps
- See all 6 Kingston Technologies, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KMF, Kingston Technologies, Inc.'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.