Instantron: FDA clearances and approvals
Instantron has 7 FDA 510(k) clearances (first 1993, latest 1994), across 1 product code in 1 review panel. Median 510(k) review time: 129 days.
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 |
|---|---|---|---|
| KCW | Epilator, High Frequency, Needle-Type | 7 | 7 |
Review panels
Most recent Instantron 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K943399 | THE SS-99 | KCW | 1994-09-16 | 64 |
| K943398 | THE BLENDTONE ROYALE | KCW | 1994-09-16 | 64 |
| K943396 | THE ELITE SPECTRUM | KCW | 1994-09-16 | 64 |
| K941227 | SHORTWAVE EPILATOR FOR PERMANENT HAIR REMOVAL | KCW | 1994-08-18 | 163 |
| K931064 | THE BLENDTONE EPILATOR | KCW | 1993-07-08 | 129 |
| K931063 | THE ELITE EPILATOR | KCW | 1993-07-08 | 129 |
| K931062 | THE VP500 EPILATOR | KCW | 1993-07-08 | 129 |
Recalls
openFDA lists no recalls under a recalling firm named Instantron.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Instantron have?
Instantron has 7 FDA 510(k) clearances (first 1993, latest 1994), across 1 product code in 1 review panel.
How long does FDA take to clear Instantron's 510(k)s?
The median time from FDA receipt to decision across Instantron's cleared 510(k)s is 129 days.
What devices does Instantron make?
Its most frequent FDA product codes are KCW (Epilator, High Frequency, Needle-Type, 7).
Has Instantron had device recalls?
openFDA lists no recalls under a recalling firm name matching Instantron. Related entities may recall under other names.
Next steps
- See all 7 Instantron clearances with predicates and recalls
- Run predicate analysis for product code KCW, Instantron's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.