510(k) · Cleared
ClearedErbe Helix Hydro-Jet
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 Jan 30, 2004 as substantially equivalent to K022613 (Erbe USA, Inc., 2002) after an 81-day review. Its family tree reaches back 4 generations to 1995. 16 later devices descend from it.
- Decided
- Jan 30, 2004
- Review
- 81 days
- Class
- Class II
- Product code
- FQH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K952726 (1995). 8 ancestors in all. 16 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK952726 Ultracision Harmonic ScapelUltracision, Inc. · 1995
- 3 generations backK990430 Ultracision Harmonic Scalpel Hand PieceEthicon Endo-Surgery, Inc. · 1999
- 2 generations backK012464 Helix Hydro-JetAndreas Pein Medizintechnik GmbH · 2001
- 1 generation backK022613 Helix Hydro-JetErbe USA, Inc. · 2002
- This deviceK033590 Erbe Helix Hydro-JetErbe USA, Inc. · 2004
- Descendant · cites it directly · 14 of its ownK072404 Erbe Erbejet 2 SystemErbe USA, Inc. · 2007
- Descendant · cites it directly · 14 of its ownK062712 Erbe Monopolar Attachment for Helix Hydro-Jet, Model P/N 20139-094Erbe USA, Inc. · 2007
- Descendant · 2 generations on · 13 of its ownK083608 Erbe Hybrid KnifeErbe USA, 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
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K072404Erbe Erbejet 2 SystemErbe USA, Inc. · 2007 · cites it directly14descendants
- K062712Erbe Monopolar Attachment for Helix Hydro-Jet, Model P/N 20139-094Erbe USA, Inc. · 2007 · cites it directly14descendants
- K083608Erbe Hybrid KnifeErbe USA, Inc. · 2009 · 2 generations on13descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K952726 | Ultracision Harmonic Scapel | Ultracision, Inc. | 1995 | — |
| −3 | K990430 | Ultracision Harmonic Scalpel Hand Piece | Ethicon Endo-Surgery, Inc. | 1999 | — |
| −2 | K012464 | Helix Hydro-Jet | Andreas Pein Medizintechnik GmbH | 2001 | — |
| −1 | K022613 | Helix Hydro-Jet | Erbe USA, Inc. | 2002 | — |
| 0 (this device) | K033590 | Erbe Helix Hydro-Jet | Erbe USA, Inc. | 2004 | — |
| +1 | K072404 | Erbe Erbejet 2 System | Erbe USA, Inc. | 2007 | — |
| +1 | 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 | — |
| +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 |
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 |
|---|---|---|
| 2007 | 2 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K022613 | Helix Hydro-JetSummary page 1…e same as the predicate except for slight modifications to the unit's suction connector/tubing as well as the suction container and bag since the last 510(k) submission (K022613). The suction connector/tubing was change so that only 111-2… | 2002 |
What descends from it? (16)
See all 162 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 9 years and passes through 4 companies; a new generation was cleared every 2.6 years on median.
- 1 of the 8 ancestors has a recall of any class.
- Of its descendants, K072404 (Erbe USA, Inc., 2007) has gone furthest, with 14 descendants of its own.
- 1 other device also cites its predicate K022613.
How does its category compare?
All FQH devicesFQH Lavage, Jet: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Helix Hydro-Jet 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/K033590 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033590: Erbe Helix Hydro-Jet.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033590
Report an extraction error
Are you the manufacturer?
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