510(k) · Cleared
ClearedEmpower RF Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Broncus Medical, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Feb 22, 2019 as substantially equivalent to K120909 (Medtronic Advanced Energy, LLC, 2012) after a 94-day review. Its family tree reaches back 3 generations to 1996. 1 later device descends from it.
- Decided
- Feb 22, 2019
- Review
- 94 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K955247 (1996). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK955247 Olympus KD Series SphincterotomeOlympus America, Inc. · 1996
- 2 generations backK971328 Olympus CD-6C-1 Coagulation ElectrodeOlympus America, Inc. · 1997
- 1 generation backK120909 EC 2.7 Endoscopic CutterMedtronic Advanced Energy, LLC · 2012
- This deviceK183240 Empower RF CatheterBroncus Medical, Inc. · 2019
- Descendant · cites it directly · 0 of its ownK200702 EasyPath RF Introducer SheathBroncus Medical, Inc. · 2021
Most influential descendants
Showing 1 of 1 · See all- K200702EasyPath RF Introducer SheathBroncus Medical, Inc. · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K955247 | Olympus KD Series Sphincterotome | Olympus America, Inc. | 1996 | — |
| −2 | K971328 | Olympus CD-6C-1 Coagulation Electrode | Olympus America, Inc. | 1997 | — |
| −1 | K120909 | EC 2.7 Endoscopic Cutter | Medtronic Advanced Energy, LLC | 2012 | — |
| 0 (this device) | K183240 | Empower RF Catheter | Broncus Medical, Inc. | 2019 | — |
| +1 | K200702 | EasyPath RF Introducer Sheath | Broncus Medical, Inc. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GEI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GEI device
- #1 K231790 The InMode System with the Morpheus8 Applicatorsscore 32.7 · 21 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K120909 | EC 2.7 Endoscopic CutterSummary page 4…d accessories DEVICE CLASSIFICATION Class II, 21 CFR §878.4400 PRODUCT CODE GEI PREDICATE DEVICES EC 2.7 Endoscopic Cutter (K120909) DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION The Empower RF Catheter is a sterile, single-use monopolar endo… | 2012 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K200702 | EasyPath RF Introducer Sheath | 2021 | 0 |
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?
- The line of descent spans 23 years and passes through 3 companies; a new generation was cleared every 6.3 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K200702 (Broncus Medical, Inc., 2021) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K120909.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · GEI
52in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEI
113in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEI
4in 2025
Class I (14 since 2007) Class II/III not classified
Adverse event reports per year · GEI
7,592in 2025
MAUDE reports naming product code GEI, 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 | 50 | 51 | 21 | 2,795 |
| 2008 | 61 | 71 | 19 | 2,556 |
| 2009 | 42 | 130 | 27 | 3,591 |
| 2010 | 46 | 109 | 51 | 3,377 |
| 2011 | 35 | 135 | 32 | 4,463 |
| 2012 | 39 | 133 | 30 | 5,216 |
| 2013 | 48 | 136 | 13 | 4,897 |
| 2014 | 49 | 103 | 3 | 4,908 |
| 2015 | 47 | 123 | 4 | 4,936 |
| 2016 | 64 | 108 | 3 | 5,616 |
| 2017 | 52 | 72 | 2 | 6,073 |
| 2018 | 47 | 93 | 6 | 6,545 |
| 2019 | 48 | 93 | 5 | 7,067 |
| 2020 | 59 | 105 | 1 | 6,490 |
| 2021 | 46 | 146 | 6 | 6,354 |
| 2022 | 55 | 150 | 49 | 6,103 |
| 2023 | 65 | 104 | 27 (4) | 7,176 |
| 2024 | 59 | 125 | 22 (10) | 7,897 |
| 2025 | 52 | 113 | 4 | 7,592 |
| 2026 | 43 | 183 | 8 | — |
What is it indicated for?
The Empower RF Catheter is a single-use, electrosurgical device designed to be used with flexible bronchoscopes. It is indicated for electrosurgical procedures involving soft tissue obstructions in the upper airways and tracheobronchial tree.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K183240 · printed Nov 6, 2026
Cite this page
510(k) Report. “K183240: Empower RF Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K183240
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026