510(k) · Cleared
ClearedHR-5000 Electrosurgical Device for New Indications
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ime Co., Ltd. · KCW Epilator, High Frequency, Needle-Type
Cleared on May 4, 1988 after a 40-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 10 later devices descend from it.
- Decided
- May 4, 1988
- Review
- 40 days
- Class
- Class I
- Product code
- KCW
- Recalls
- None
- Predicates
- 0
10 later devices descend from it, 1 citing it directly.
- This deviceK881276 HR-5000 Electrosurgical Device for New IndicationsIme Co., Ltd. · 1988
- Descendant · cites it directly · 9 of its ownK160469 AGNESGowoonsesang Cosmetics Co., Ltd. · 2017
- Descendant · 2 generations on · 6 of its ownK192728 AgnesAgnes Medical Co., Ltd. · 2019
- Descendant · 3 generations on · 4 of its ownK203013 AGNESAgnes Medical Co., Ltd. · 2022
- Descendant · 4 generations on · 3 of its ownK223805 AgnesAgnes Medical Co., Ltd. · 2023
- Descendant · 5 generations on · 2 of its ownK242469 RFMagik LiteAgnes Medical Co., Ltd. · 2025
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K160469AGNESGowoonsesang Cosmetics Co., Ltd. · 2017 · cites it directly9descendants
- K192728AgnesAgnes Medical Co., Ltd. · 2019 · 2 generations on6descendants
- K203013AGNESAgnes Medical Co., Ltd. · 2022 · 3 generations on4descendants
- K223805AgnesAgnes Medical Co., Ltd. · 2023 · 4 generations on3descendants
- K242469RFMagik LiteAgnes Medical Co., Ltd. · 2025 · 5 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K881276 | HR-5000 Electrosurgical Device for New Indications | Ime Co., Ltd. | 1988 | — |
| +1 | K160469 | AGNES | Gowoonsesang Cosmetics Co., Ltd. | 2017 | — |
| +2 | K192728 | Agnes | Agnes Medical Co., Ltd. | 2019 | — |
| +3 | K203013 | AGNES | Agnes Medical Co., Ltd. | 2022 | — |
| +4 | K223805 | Agnes | Agnes Medical Co., Ltd. | 2023 | — |
| +5 | K242469 | RFMagik Lite | Agnes Medical Co., Ltd. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 4 | 0 |
| 2026 | 1 | 0 |
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? (10)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K160469 | AGNES | 2017 | 9 |
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.
What does this lineage say?
- Of its descendants, K160469 (Gowoonsesang Cosmetics Co., Ltd., 2017) has gone furthest, with 9 descendants of its own.
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/K881276 · printed Nov 6, 2026
Cite this page
510(k) Report. “K881276: HR-5000 Electrosurgical Device for New Indications.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K881276
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026