510(k) · Cleared
ClearedERBEJET® 2 System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Erbe Elektromedizin GmbH · FQH Lavage, Jet
Cleared on Jun 15, 2023 as substantially equivalent to K072404 (Erbe USA, Inc., 2007) and 1 other predicate after a 65-day review. Its family tree reaches back 8 generations to 1995. 1 later device descends from it.
- Decided
- Jun 15, 2023
- Review
- 65 days
- Class
- Class II
- Product code
- FQH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K952726 (1995). 30 ancestors in all, the oldest K894762 (1989). 1 later device descends from it, 1 citing it directly.
- Root · 8 generations backK952726 Ultracision Harmonic ScapelUltracision, Inc. · 1995
- 7 generations backK990430 Ultracision Harmonic Scalpel Hand PieceEthicon Endo-Surgery, Inc. · 1999
- 6 generations backK012464 Helix Hydro-JetAndreas Pein Medizintechnik GmbH · 2001
- 5 generations backK022613 Helix Hydro-JetErbe USA, Inc. · 2002
- 4 generations backK033590 Erbe Helix Hydro-JetErbe USA, Inc. · 2004
- 3 generations backK062712 Erbe Monopolar Attachment for Helix Hydro-Jet, Model P/N 20139-094Erbe USA, Inc. · 2007
- 2 generations backK083608 Erbe Hybrid KnifeErbe USA, Inc. · 2009
- 1 generation backK143306 ERBE WaterJet Model ERBEJET® 2 System with HybridAPC ProbeErbe USA, Inc. · 2015
- This deviceK231023 ERBEJET® 2 SystemErbe Elektromedizin GmbH · 2023
- Descendant · cites it directly · 0 of its ownK232033 HYBRIDknife® flexErbe Elektromedizin GmbH · 2023
Most influential descendants
Showing 1 of 1 · See all- K232033HYBRIDknife® flexErbe Elektromedizin GmbH · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K952726 | Ultracision Harmonic Scapel | Ultracision, Inc. | 1995 | — |
| −7 | K990430 | Ultracision Harmonic Scalpel Hand Piece | Ethicon Endo-Surgery, Inc. | 1999 | — |
| −6 | K012464 | Helix Hydro-Jet | Andreas Pein Medizintechnik GmbH | 2001 | — |
| −5 | K022613 | Helix Hydro-Jet | Erbe USA, Inc. | 2002 | — |
| −4 | K033590 | Erbe Helix Hydro-Jet | Erbe USA, Inc. | 2004 | — |
| −3 | K062712 | Erbe Monopolar Attachment for Helix Hydro-Jet, Model P/N 20139-094 | Erbe USA, Inc. | 2007 | — |
| −2 | K083608 | Erbe Hybrid Knife | Erbe USA, Inc. | 2009 | — |
| −1 | K143306 | ERBE WaterJet Model ERBEJET® 2 System with HybridAPC Probe | Erbe USA, Inc. | 2015 | — |
| 0 (this device) | K231023 | ERBEJET® 2 System | Erbe Elektromedizin GmbH | 2023 | — |
| +1 | K232033 | HYBRIDknife® flex | Erbe Elektromedizin GmbH | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 4 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2009 | 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 FQH? 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 FQH device
- #1 K253996 BD Surgiphor™ Antimicrobial Irrigation System…score 14.8 · 14 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 |
|---|---|---|---|
| * | K072404 | Erbe Erbejet 2 SystemSummary page 4…75 Class: II Product Code: FQH Legally Marketed Predicate Devices ERBE ERBEJET 2 System - K072404 and ERBE Water Jet Model ERBEJET® 2 System… | 2007 |
| * | K143306 | ERBE WaterJet Model ERBEJET® 2 System with HybridAPC ProbeSummary page 4…ystem - K072404 and ERBE Water Jet Model ERBEJET® 2 System with HybridAPC Probe - K143306 Device Description The ERBEJET® 2 System includes the Hydrosurgical unit model ERBEJET® 2, the pump cartridge plus, instrument… | 2015 |
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 |
|---|---|---|---|
| K232033 | HYBRIDknife® flex | 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 28 years and passes through 5 companies; a new generation was cleared every 3.0 years on median.
- 2 of the 30 ancestors have a recall of any class.
- Of its descendants, K232033 (Erbe Elektromedizin GmbH, 2023) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K072404.
How does its category compare?
All FQH devicesFQH Lavage, Jet: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · FQH
3in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · FQH
410in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FQH
2in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FQH
835in 2025
MAUDE reports naming product code FQH, 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 | 1 | — | 13 | 10 |
| 2008 | 0 | — | 0 | 27 |
| 2009 | 3 | 240 | 1 | 70 |
| 2010 | 0 | — | 7 | 135 |
| 2011 | 2 | — | 0 | 83 |
| 2012 | 1 | — | 0 | 133 |
| 2013 | 0 | — | 0 | 134 |
| 2014 | 0 | — | 0 | 194 |
| 2015 | 1 | — | 0 | 116 |
| 2016 | 1 | — | 0 | 150 |
| 2017 | 0 | — | 1 | 243 |
| 2018 | 0 | — | 0 | 317 |
| 2019 | 0 | — | 2 | 328 |
| 2020 | 3 | 130 | 0 | 393 |
| 2021 | 1 | — | 0 | 398 |
| 2022 | 4 | 136 | 0 | 171 |
| 2023 | 3 | 410 | 0 | 333 |
| 2024 | 0 | — | 0 | 425 |
| 2025 | 0 | — | 0 | 835 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
Indications for Use - Hydrosurgical unit: The Erbe hydrosurgical unit ERBEJET 2 with instruments and accessories is intended to pressurize a medium to perform needle-free injection and tissue-selective hydrodissection of soft tissue. The Erbe hydrosurgical unit ERBEJET 2 with instruments and accessories is used in endoscopic and surgical procedures. Indications for Use - Applicators and ERBEJET probe: 20150-220: The ERBEJET probe is intended for…
Read the full statement (232 words)
Indications for Use - Hydrosurgical unit:
The Erbe hydrosurgical unit ERBEJET 2 with instruments and accessories is intended to pressurize a medium to perform needle-free injection and tissue-selective hydrodissection of soft tissue. The Erbe hydrosurgical unit ERBEJET 2 with instruments and accessories is used in endoscopic and surgical procedures.
Indications for Use - Applicators and ERBEJET probe:
20150-220: The ERBEJET probe is intended for dissection (tissue-selective hydrodissection) including separation of soft tissue in endoscopic interventions. The ERBEJET probe can be used for needle-free injection including lifting of mucosal lesions by injection into the submucosa.
20150-225: The applicator is intended for dissection (tissue-selective hydrodissection) including separation of soft tissue in open surgery.
20150-226: The applicator is intended for dissection (tissue-selective hydrodissection) including separation of soft tissue in minimal invasive surgery. The applicator can be used for needle-free injection including lifting of mucosal lesions by injection into the submucosa.
20150-230, 20150-231, 20150-239: The applicators with suction are intended for dissection (tissue-selective hydrodissection) including separation of soft tissue in open surgery. The applicators with suction can be used as well for suction when connected to an external suction module e.g. Erbe ESM 2.
20150-238: The applicator with suction is intended for dissection (tissue-selective hydrodissection) including separation of soft tissue in minimal invasive surgery. The applicator with suction can be used as well for suction when connected to an external suction module e.g. Erbe ESM 2.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231023 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231023: ERBEJET® 2 System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231023
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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