510(k) · Cleared
ClearedErbe Erbejet 2 System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Erbe USA, Inc. · FQH Lavage, Jet
Cleared on Oct 31, 2007 as substantially equivalent to K033590 (Erbe USA, Inc., 2004) and 2 other predicates after a 65-day review. Its family tree reaches back 5 generations to 1995. 14 later devices descend from it.
- Decided
- Oct 31, 2007
- Review
- 65 days
- Class
- Class II
- Product code
- FQH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K952726 (1995). 9 ancestors in all. 14 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK952726 Ultracision Harmonic ScapelUltracision, Inc. · 1995
- 4 generations backK990430 Ultracision Harmonic Scalpel Hand PieceEthicon Endo-Surgery, Inc. · 1999
- 3 generations backK012464 Helix Hydro-JetAndreas Pein Medizintechnik GmbH · 2001
- 2 generations backK022613 Helix Hydro-JetErbe USA, Inc. · 2002
- 1 generation backK033590 Erbe Helix Hydro-JetErbe USA, Inc. · 2004
- This deviceK072404 Erbe Erbejet 2 SystemErbe USA, Inc. · 2007
- Descendant · cites it directly · 13 of its ownK083608 Erbe Hybrid KnifeErbe USA, 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 · cites it directly · 1 of its ownK231023 ERBEJET® 2 SystemErbe Elektromedizin GmbH · 2023
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K083608Erbe Hybrid KnifeErbe USA, Inc. · 2009 · cites it directly13descendants
- 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 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K952726 | Ultracision Harmonic Scapel | Ultracision, Inc. | 1995 | — |
| −4 | K990430 | Ultracision Harmonic Scalpel Hand Piece | Ethicon Endo-Surgery, Inc. | 1999 | — |
| −3 | K012464 | Helix Hydro-Jet | Andreas Pein Medizintechnik GmbH | 2001 | — |
| −2 | K022613 | Helix Hydro-Jet | Erbe USA, Inc. | 2002 | — |
| −1 | K033590 | Erbe Helix Hydro-Jet | Erbe USA, Inc. | 2004 | — |
| 0 (this device) | K072404 | Erbe Erbejet 2 System | Erbe USA, Inc. | 2007 | — |
| +1 | K083608 | Erbe Hybrid Knife | Erbe USA, 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 | — |
| +1 | K231023 | ERBEJET® 2 System | Erbe Elektromedizin GmbH | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 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 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? (3)
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 |
|---|---|---|---|
| * | K033590 | Erbe Helix Hydro-JetSummary page 1…ssification Name: Jet Lavage (21 CFR Part 880.5475) Product Code: FQH Legally Marketed ERBE Helix Hydro-Jet TM System, 510(k) Numbers: K033590; Predicate Devices: K022613; K012464 Device Description: The ERBEJET® 2 System delivers pressurized normal saline s… | 2004 |
| * | K022613 | Helix Hydro-JetSummary page 1…21 CFR Part 880.5475) Product Code: FQH Legally Marketed ERBE Helix Hydro-Jet TM System, 510(k) Numbers: K033590; Predicate Devices: K022613; K012464 Device Description: The ERBEJET® 2 System delivers pressurized normal saline solution (0.9% saline solution for… | 2002 |
| * | K012464 | Helix Hydro-JetSummary page 1…rt 880.5475) Product Code: FQH Legally Marketed ERBE Helix Hydro-Jet TM System, 510(k) Numbers: K033590; Predicate Devices: K022613; K012464 Device Description: The ERBEJET® 2 System delivers pressurized normal saline solution (0.9% saline solution for irrigatio… | 2001 |
| † | K061205 | Medela Vario 8/18/CI Secretion & Surgical Aspirator | 2006 |
| † | K043544 | Medela Dominant 35 C/I Secretion and Surgical Aspirator | 2005 |
What descends from it? (14)
See all 143 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?
- The line of descent spans 12 years and passes through 4 companies; a new generation was cleared every 2.6 years on median.
- 1 of the 9 ancestors has a recall of any class.
- Of its descendants, K083608 (Erbe USA, Inc., 2009) has gone furthest, with 13 descendants of its own.
- 1 other device also cites its predicate K033590.
How does its category compare?
All FQH devicesFQH Lavage, Jet: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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?
The ERBEJET® 2 System is intended for the cutting and dissection of soft tissue in neurosurgery and soft tissue such as the liver, kidney, etc. within the abdomen, including Total Mesorectal Excision (TME), in open as well as endoscopic surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072404 · printed Nov 4, 2026
Cite this page
510(k) Report. “K072404: Erbe Erbejet 2 System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072404
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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