510(k) · Cleared
ClearedNeedle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
United States Endoscopy Group, Inc. · FBK Endoscopic Injection Needle, Gastroenterology-Urology
Cleared on Nov 25, 1992 after a 104-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 19 later devices descend from it.
- Decided
- Nov 25, 1992
- Review
- 104 days
- Class
- Class II
- Product code
- FBK
- Recalls
- None
- Predicates
- 0
19 later devices descend from it, 2 citing it directly.
- This deviceK924102 NeedleUnited States Endoscopy Group, Inc. · 1992
- Descendant · cites it directly · 13 of its ownK092090 Erbelift Hand Pump and Flexible ProbeByrne Medical, Inc. · 2009
- Descendant · 2 generations on · 12 of its ownK143306 ERBE WaterJet Model ERBEJET® 2 System with HybridAPC ProbeErbe USA, Inc. · 2015
- Descendant · 3 generations on · 7 of its ownK171158 Single Use Electrosurgical knifeOlympus Medical Systems Corp. · 2017 · Recalled
- Descendant · cites it directly · 4 of its ownK103235 Erbeflo 2 Disposable Tubing SystemErbe USA, Inc. · 2010
- Descendant · 3 generations on · 1 of its ownK243120 HybridAPC probeErbe Elektromedizin GmbH · 2025
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · See all- K092090Erbelift Hand Pump and Flexible ProbeByrne Medical, Inc. · 2009 · cites it directly13descendants
- K143306ERBE WaterJet Model ERBEJET® 2 System with HybridAPC ProbeErbe USA, Inc. · 2015 · 2 generations on12descendants
- K171158Single Use Electrosurgical knifeOlympus Medical Systems Corp. · 2017 · 3 generations on7descendants
- K103235Erbeflo 2 Disposable Tubing SystemErbe USA, Inc. · 2010 · cites it directly4descendants
- K243120HybridAPC probeErbe Elektromedizin GmbH · 2025 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K924102 | Needle | United States Endoscopy Group, Inc. | 1992 | — |
| +1 | K092090 | Erbelift Hand Pump and Flexible Probe | Byrne Medical, Inc. | 2009 | — |
| +2 | K143306 | ERBE WaterJet Model ERBEJET® 2 System with HybridAPC Probe | Erbe USA, Inc. | 2015 | — |
| +3 | K171158 | Single Use Electrosurgical knife | Olympus Medical Systems Corp. | 2017 | 2 |
| +1 | K103235 | Erbeflo 2 Disposable Tubing System | Erbe USA, Inc. | 2010 | — |
| +3 | K243120 | HybridAPC probe | Erbe Elektromedizin GmbH | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 3 | 0 |
| 2020 | 3 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2025 | 3 | 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 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (19)
See all 192 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K092090 (Byrne Medical, Inc., 2009) has gone furthest, with 13 descendants of its own.
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.
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 | — |
https://510kreport.com/device/K924102 · printed Nov 6, 2026
Cite this page
510(k) Report. “K924102: Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K924102
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026