510(k) · Cleared
ClearedErbelift Hand Pump and Flexible Probe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Byrne Medical, Inc. · FBK Endoscopic Injection Needle, Gastroenterology-Urology
Cleared on Nov 30, 2009 as substantially equivalent to K924102 (United States Endoscopy Group, Inc., 1992) and 1 other predicate after a 139-day review. Its family tree reaches back 1 generation to 1992. 13 later devices descend from it.
- Decided
- Nov 30, 2009
- Review
- 139 days
- Class
- Class II
- Product code
- FBK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K924102 (1992). 2 ancestors in all. 13 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK924102 NeedleUnited States Endoscopy Group, Inc. · 1992
- This deviceK092090 Erbelift Hand Pump and Flexible ProbeByrne Medical, Inc. · 2009
- Descendant · cites it directly · 12 of its ownK143306 ERBE WaterJet Model ERBEJET® 2 System with HybridAPC ProbeErbe USA, Inc. · 2015
- Descendant · 2 generations on · 7 of its ownK171158 Single Use Electrosurgical knifeOlympus Medical Systems Corp. · 2017 · Recalled
- Descendant · 2 generations on · 1 of its ownK243120 HybridAPC probeErbe Elektromedizin GmbH · 2025
- Descendant · 2 generations on · 1 of its ownK231023 ERBEJET® 2 SystemErbe Elektromedizin GmbH · 2023
- Descendant · 3 generations on · 1 of its ownK193601 Single Use Electrosurgical KnifeMicro-Tech (Nanjing) Co., Ltd. · 2020
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K143306ERBE WaterJet Model ERBEJET® 2 System with HybridAPC ProbeErbe USA, Inc. · 2015 · cites it directly12descendants
- K171158Single Use Electrosurgical knifeOlympus Medical Systems Corp. · 2017 · 2 generations on7descendants
- K243120HybridAPC probeErbe Elektromedizin GmbH · 2025 · 2 generations on1descendant
- K231023ERBEJET® 2 SystemErbe Elektromedizin GmbH · 2023 · 2 generations on1descendant
- K193601Single Use Electrosurgical KnifeMicro-Tech (Nanjing) Co., Ltd. · 2020 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K924102 | Needle | United States Endoscopy Group, Inc. | 1992 | — |
| 0 (this device) | K092090 | Erbelift Hand Pump and Flexible Probe | Byrne Medical, Inc. | 2009 | — |
| +1 | K143306 | ERBE WaterJet Model ERBEJET® 2 System with HybridAPC Probe | Erbe USA, Inc. | 2015 | — |
| +2 | K171158 | Single Use Electrosurgical knife | Olympus Medical Systems Corp. | 2017 | 2 |
| +2 | K243120 | HybridAPC probe | Erbe Elektromedizin GmbH | 2025 | — |
| +2 | K231023 | ERBEJET® 2 System | Erbe Elektromedizin GmbH | 2023 | — |
| +3 | K193601 | Single Use Electrosurgical Knife | Micro-Tech (Nanjing) Co., Ltd. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 3 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2025 | 3 | 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 FBK? 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 FBK device
- #1 K253598 InjecSURE Injection Systemscore 12.9 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K924102 | NeedleSummary page 1…oscopic Injection Needle (21 CFR Part 876.1500) Product Code: FBK Legally Marketed Predicate Device: Endoscopic Injection Needle 510(k) Number: K924102 and Endoscopid Injection Needle/Snare 510(k) Number: K(040961 Device Des… | 1992 |
| * | K040961 | Injector Needle/SnareSummary page 1…Endoscopic Injection Needle 510(k) Number: K924102 and Endoscopid Injection Needle/Snare 510(k) Number: K(040961 Device Description: The ERBELIFT T m Hand Pump and Flexible Probe are used for the delivery of pressurized sterile normal sali… | 2004 |
What descends from it? (13)
See all 131 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K143306 | ERBE WaterJet Model ERBEJET® 2 System with HybridAPC Probe | 2015 | 12 |
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?
How does its category compare?
All FBK devicesFBK Endoscopic Injection Needle, Gastroenterology-Urology: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · FBK
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FBK
155in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FBK
9in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FBK
81in 2025
MAUDE reports naming product code FBK, 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 | 3 |
| 2008 | 1 | — | 0 | 22 |
| 2009 | 4 | 101 | 0 | 12 |
| 2010 | 0 | — | 0 | 12 |
| 2011 | 1 | — | 0 | 2 |
| 2012 | 2 | — | 0 | 2 |
| 2013 | 0 | — | 0 | 3 |
| 2014 | 2 | — | 0 | 9 |
| 2015 | 3 | 103 | 0 | 4 |
| 2016 | 2 | — | 1 | 18 |
| 2017 | 3 | 51 | 0 | 27 |
| 2018 | 2 | — | 0 | 9 |
| 2019 | 1 | — | 0 | 6 |
| 2020 | 2 | — | 0 | 25 |
| 2021 | 1 | — | 20 | 34 |
| 2022 | 6 | 213 | 8 | 80 |
| 2023 | 3 | 177 | 1 | 60 |
| 2024 | 4 | 192 | 9 | 94 |
| 2025 | 3 | 155 | 0 | 81 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
The ERBELIFT Hand Pump in conjunction with an ERBELIFT Flexible Probe is indicated for the induction of sterile normal saline into the submucosa to lift polyps or other mucosal lesions using direct visualization through a flexible endoscope.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092090 · printed Nov 4, 2026
Cite this page
510(k) Report. “K092090: Erbelift Hand Pump and Flexible Probe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092090
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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