510(k) · Cleared
ClearedBipolar applicator CelonProBreath (WB990310); Bipolar applicator CelonProSleep plus (WB990311); Bipolar applicator CelonProBreath (WB990210); Bipolar applicator CelonProSleep plus (WB990211)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus Winter & Ibe GmbH · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Sep 23, 2025 as substantially equivalent to K032838 (Celon AG Medical Instruments, 2003) after an 85-day review. Its family tree reaches back 6 generations to 1995.
- Decided
- Sep 23, 2025
- Review
- 85 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K943450 (1995). 20 ancestors in all, the oldest K800617 (1980). No later device cites it as a predicate yet.
- Root · 6 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 5 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 4 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 3 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 2 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 1 generation backK032838 Celon Ent SystemCelon AG Medical Instruments · 2003
- This deviceK252043 Bipolar applicator CelonProBreath (WB990310); Bipolar applicator…Olympus Winter & Ibe GmbH · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −5 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −4 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −3 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −2 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −1 | K032838 | Celon Ent System | Celon AG Medical Instruments | 2003 | — |
| 0 (this device) | K252043 | Bipolar applicator CelonProBreath (WB990310); Bipolar applicator CelonProSleep… | Olympus Winter & Ibe GmbH | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1992 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 4 | 0 |
| 1997 | 2 | 0 |
| 2000 | 2 | 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 |
|---|---|---|---|
| * | K032838 | Celon Ent SystemSummary page 6…cate Device Article Number Manufacturer 510(k) Number CelonProBreath WB990210 Olympus Winter & Ibe GmbH K032838 CelonProSleep PLUS WB990211 Olympus Winter & Ibe GmbH K032838 4 Product Description The devices subj… | 2003 |
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.
What does this lineage say?
- The line of descent spans 30 years and passes through 3 companies; a new generation was cleared every 1.2 years on median.
- 1 of the 20 ancestors has a recall of any class.
- 2 other devices also cite its predicate K032838.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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?
Bipolar applicator CelonProBreath is intended for use with a compatible electrosurgical generator. This method of treatment is also called bipolar Radiofrequency Induced Thermotherapy (RFITT). Bipolar applicator CelonProBreath is indicated for ablation and coagulation of soft tissue in otorhinolaryngeal surgery, specifically: - Shrinkage of submucosal tissue in nasal airway obstruction by reduction of hypertrophic nasal turbinates. The product is…
Read the full statement (141 words)
Bipolar applicator CelonProBreath is intended for use with a compatible electrosurgical generator. This method of treatment is also called bipolar Radiofrequency Induced Thermotherapy (RFITT).
Bipolar applicator CelonProBreath is indicated for ablation and coagulation of soft tissue in otorhinolaryngeal surgery, specifically:
- Shrinkage of submucosal tissue in nasal airway obstruction by reduction of hypertrophic nasal turbinates.
The product is intended to be used for patients from 2 years and up.
Bipolar applicator CelonProSleep plus is intended for use with a compatible electrosurgical generator. This method of treatment is also called bipolar radiofrequency induced thermotherapy (RFITT).
Bipolar applicator CelonProSleep plus is indicated for ablation and coagulation of soft tissue in otorhinolaryngeal surgery, specifically:
- Shrinkage of submucosal tissue and tissue coagulation in the soft palate for the treatment of snoring.
The product is intended to be used for patients from 18 years up.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252043 · printed Nov 6, 2026
Cite this page
510(k) Report. “K252043: Bipolar applicator CelonProBreath (WB990310); Bipolar applicator CelonProSleep plus (WB990311); Bipolar applicator CelonProBreath (WB990210); Bipolar applicator CelonProSleep plus (WB990211).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K252043
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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