510(k) · Cleared
ClearedSterex Sterile Disposale Electrolysis Needle for Use in Epilation
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sterex Electrolysis Intl., Ltd. · KCW Epilator, High Frequency, Needle-Type
Cleared on Oct 18, 1995 after a 133-day review. FDA has not posted a summary or statement for it, so its predicates are not known.
- Decided
- Oct 18, 1995
- Review
- 133 days
- Class
- Class I
- Product code
- KCW
- Recalls
- None
- Predicates
- 0
FDA has not posted a summary or statement for it, so its predicates are not known.
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KCW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All KCW devicesKCW Epilator, High Frequency, Needle-Type: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KCW
FDA has decided no KCW device since 2007.
Median 510(k) review, days · KCW
Too few KCW 510(k)s in any year since 2007 to give a median.
Recalls per year · KCW
No recall names KCW since 2007.
Adverse event reports per year · KCW
2in 2020
MAUDE reports naming product code KCW, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K952611 · printed Nov 6, 2026
Cite this page
510(k) Report. “K952611: Sterex Sterile Disposale Electrolysis Needle for Use in Epilation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K952611
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026