510(k) · Cleared
ClearedAdeor Medical nxt Non-stick Bipolar Forceps, Adeor Medical nxt Single-Use Non-stick Bipolar Forceps
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Adeor Medical AG · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on May 22, 2020 as substantially equivalent to K182773 (Faulhaber Pinzetten Ohg, 2019) after a 317-day review. Its family tree reaches back 3 generations to 1988. 1 later device descends from it.
- Decided
- May 22, 2020
- Review
- 317 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K884656 (1988). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK884656 Disposable Bipolar Cord and Bipolar ForcepDermacare · 1988 · Recalled
- 2 generations backK080187 Olsen Medical Single Use Bayonet Bipolar Irrigating ForcepsOlsen Medical · 2008 · Recalled
- 1 generation backK182773 Single-Use Non-Stick Bipolar forceps Bayonet, Single-Use Non-Stick…Faulhaber Pinzetten Ohg · 2019
- This deviceK191847 Adeor Medical nxt Non-stick Bipolar Forceps, Adeor Medical nxt…Adeor Medical AG · 2020
- Descendant · cites it directly · 0 of its ownK233351 Single Use Non-Stick McPherson Bipolar Forceps, 110mm, 0.5mm Tip…Hg Innovations, Ltd. · 2023
Most influential descendants
Showing 1 of 1 · See all- K233351Single Use Non-Stick McPherson Bipolar Forceps, 110mm, 0.5mm Tip with Cable…Hg Innovations, Ltd. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K884656 | Disposable Bipolar Cord and Bipolar Forcep | Dermacare | 1988 | 1 |
| −2 | K080187 | Olsen Medical Single Use Bayonet Bipolar Irrigating Forceps | Olsen Medical | 2008 | 1 |
| −1 | K182773 | Single-Use Non-Stick Bipolar forceps Bayonet, Single-Use Non-Stick Bipolar… | Faulhaber Pinzetten Ohg | 2019 | — |
| 0 (this device) | K191847 | Adeor Medical nxt Non-stick Bipolar Forceps, Adeor Medical nxt Single-Use… | Adeor Medical AG | 2020 | — |
| +1 | K233351 | Single Use Non-Stick McPherson Bipolar Forceps, 110mm, 0.5mm Tip with Cable… | Hg Innovations, Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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 |
|---|---|---|---|
| * | K182773 | Single-Use Non-Stick Bipolar forceps Bayonet, Single-Use Non-Stick Bipolar Irrigating… Cleared while this submission was under review Summary page 4…es Device Classification: II Reviewing Panel: General and Plastic Surgery Product Code: GEI Predicate Device: K182773 Falhaber Pinzetten OHG Non-Stick Bipolar Forceps (never subject to recall) Reference Predicates:… | 2019 |
| † | K101080 | Non Stick Bipolar Forceps Model 07/XXX, Bipolar Forceps Model 08/XXX, Monopolar Forceps… | 2010 |
| † | K162469 | CODMAN VersaTru Standard Disposable Non-Stick Bipolar Forceps, CODMAN VersaTru Slim… | 2016 |
| † | K130669 | Single Use & Multi Use Bipolar Forceps / Single Use & Multi Use Monopolar Forceps | 2013 |
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 |
|---|---|---|---|
| K233351 | Single Use Non-Stick McPherson Bipolar Forceps, 110mm, 0.5mm Tip with Cable… | 2023 | 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 32 years and passes through 4 companies; a new generation was cleared every 11.4 years on median.
- 2 of the 5 ancestors have a recall of any class.
- Of its descendants, K233351 (Hg Innovations, Ltd., 2023) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K182773.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 Adeor Medical Non-stick Bipolar Forceps are intended for use by a physician familiar with electrosurgery in bipolar coagulation for general open surgery where coagulation of soft tissue is needed. Adeor bipolar forceps must be operated with the following parameters: Frequency range between 300 kHz and 1,000 kHZ; maximum generator operating voltage 600Vp. The Adeor Medical Non-stick Bipolar Forceps have not been shown to be effective for tubal…
Read the full statement (115 words)
The Adeor Medical Non-stick Bipolar Forceps are intended for use by a physician familiar with electrosurgery in bipolar
coagulation for general open surgery where coagulation of soft tissue is needed. Adeor bipolar forceps must be operated
with the following parameters: Frequency range between 300 kHz and 1,000 kHZ; maximum generator operating voltage
600Vp.
The Adeor Medical Non-stick Bipolar Forceps have not been shown to be effective for tubal sterilization or tubal
coagulation for sterilization procedures and should not be used for these procedures.
The types of surgery intended include:
- ENT
- Gynecology (except for use in female sterilization)
- Urology
- General surgery
- Neurosurgery
- Laryngeal Surgery
- Orthopedic Surgery
- Thoracic Surgery
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191847 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191847: Adeor Medical nxt Non-stick Bipolar Forceps, Adeor Medical nxt Single-Use Non-stick Bipolar Forceps.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191847
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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