510(k) Report

510(k) · Cleared

Cleared

Helix Hydro-Jet

K022613510(k) TraditionalCleared Oct 25, 200280-day reviewClass II21 CFR 880.5475

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Erbe USA, Inc. · FQH Lavage, Jet

Cleared on Oct 25, 2002 as substantially equivalent to K012464 (Andreas Pein Medizintechnik GmbH, 2001) after an 80-day review. Its family tree reaches back 3 generations to 1995. 17 later devices descend from it.

Decided
Oct 25, 2002
Review
80 days
Class
Class II
Product code
FQH
Recalls
None
Predicates
1

Its longest line of descent runs back 3 generations to K952726 (1995). 7 ancestors in all. 17 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2000: 2 other ancestors1998: 1 other ancestor1997: 1 other ancestor2007: 2 descendants cleared2004: 1 descendant cleared2023: 2 descendants cleared2009: 1 descendant cleared2015: 1 descendant cleared2020: 3 descendants cleared2017: 1 descendant cleared2025: 3 descendants cleared2022: 1 descendant cleared2019: 1 descendant cleared2021: 1 descendant clearedK952726 · Ultracision Harmonic Scapel · Ultracision, Inc. · 1995K990430 · Ultracision Harmonic Scalpel Hand Piece · Ethicon Endo-Surgery, Inc. · 1999K012464 · Helix Hydro-Jet · Andreas Pein Medizintechnik GmbH · 20011995200020052010201520202025
Other ancestors, by generationDescendants, by generation 2 generations back: 3 other ancestors3 generations back: 1 other ancestor 1 generation forward: 2 descendants2 generations forward: 4 descendants3 generations forward: 4 descendants4 generations forward: 6 descendants5 generations forward: 1 descendant K012464 · Helix Hydro-Jet · Andreas Pein Medizintechnik GmbH · 2001K990430 · Ultracision Harmonic Scalpel Hand Piece · Ethicon Endo-Surgery, Inc. · 1999K952726 · Ultracision Harmonic Scapel · Ultracision, Inc. · 19950+5
  1. Root · 3 generations backK952726 Ultracision Harmonic ScapelUltracision, Inc. · 1995
  2. 2 generations backK990430 Ultracision Harmonic Scalpel Hand PieceEthicon Endo-Surgery, Inc. · 1999
  3. 1 generation backK012464 Helix Hydro-JetAndreas Pein Medizintechnik GmbH · 2001
  4. This deviceK022613 Helix Hydro-JetErbe USA, Inc. · 2002
  5. Descendant · cites it directly · 16 of its ownK033590 Erbe Helix Hydro-JetErbe USA, Inc. · 2004
  6. Descendant · cites it directly · 14 of its ownK072404 Erbe Erbejet 2 SystemErbe USA, Inc. · 2007
  7. Descendant · 2 generations on · 14 of its ownK062712 Erbe Monopolar Attachment for Helix Hydro-Jet, Model P/N 20139-094Erbe USA, Inc. · 2007
  8. Descendant · 2 generations on · 13 of its ownK083608 Erbe Hybrid KnifeErbe USA, Inc. · 2009
  9. Descendant · 2 generations on · 12 of its ownK143306 ERBE WaterJet Model ERBEJET® 2 System with HybridAPC ProbeErbe USA, Inc. · 2015

Showing 5 of 17 descendants. See all descendants

Descendants cleared per year

2004: 12007: 22009: 12015: 12017: 12019: 12020: 32021: 12022: 12023: 22025: 3
2004high 3 (2020) · low 0 (2005)2026

Most influential descendants

Showing 5 of 17 · See all
  • K033590Erbe Helix Hydro-JetErbe USA, Inc. · 2004 · cites it directly16descendants
  • 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 · 2 generations on14descendants
  • K083608Erbe Hybrid KnifeErbe USA, Inc. · 2009 · 2 generations on13descendants
  • K143306ERBE WaterJet Model ERBEJET® 2 System with HybridAPC ProbeErbe USA, Inc. · 2015 · 2 generations on12descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K952726Ultracision Harmonic ScapelUltracision, Inc.1995—
−2K990430Ultracision Harmonic Scalpel Hand PieceEthicon Endo-Surgery, Inc.1999—
−1K012464Helix Hydro-JetAndreas Pein Medizintechnik GmbH2001—
0 (this device)K022613Helix Hydro-JetErbe USA, Inc.2002—
+1K033590Erbe Helix Hydro-JetErbe USA, Inc.2004—
+1K072404Erbe Erbejet 2 SystemErbe USA, Inc.2007—
+2K062712Erbe Monopolar Attachment for Helix Hydro-Jet, Model P/N 20139-094Erbe USA, Inc.2007—
+2K083608Erbe Hybrid KnifeErbe USA, Inc.2009—
+2K143306ERBE WaterJet Model ERBEJET® 2 System with HybridAPC ProbeErbe USA, Inc.2015—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199710
199810
200020

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200720
200910
201510
201710
201910
202030
202110
202210
202320
202530
FIG. 1 — Lineage of K022613, 1995–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K253996 BD Surgiphor™ Antimicrobial Irrigation System…score 14.8 · 14 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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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.

TypeNumberDeviceApplicantDecidedRecalls
*K012464Helix Hydro-JetAndreas Pein Medizintechnik GmbH2001—

Also cleared against K012464: 2 other devices →

What descends from it? (17)

See all 17

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K033590Erbe Helix Hydro-JetErbe USA, Inc.200416
K072404Erbe Erbejet 2 SystemErbe USA, Inc.200714

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 7 years and passes through 4 companies; a new generation was cleared every 2.6 years on median.
  • 1 of the 7 ancestors has a recall of any class.
  • Of its descendants, K033590 (Erbe USA, Inc., 2004) has gone furthest, with 16 descendants of its own.
  • 2 other devices also cite its predicate K012464.

How does its category compare?

All FQH devices

FQH Lavage, Jet: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FQH

3in 2023

2007: 12009: 32011: 22012: 12015: 12016: 12020: 32021: 12022: 42023: 32026 (partial year): 2
2007high 4 (2022) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FQH

410in 2023

2009: 240 days median2020: 130 days median2022: 136 days median2023: 410 days median
2007high 410 (2023) · low 130 (2020)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FQH

2in 2019

2007: 132009: 12010: 72017: 12019: 2
2007high 13 (2007) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · FQH

835in 2025

2007: 102008: 272009: 702010: 1352011: 832012: 1332013: 1342014: 1942015: 1162016: 1502017: 2432018: 3172019: 3282020: 3932021: 3982022: 1712023: 3332024: 4252025: 835
2007high 835 (2025) · low 10 (2007)2025

MAUDE reports naming product code FQH, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—1310
20080—027
20093240170
20100—7135
20112—083
20121—0133
20130—0134
20140—0194
20151—0116
20161—0150
20170—1243
20180—0317
20190—2328
202031300393
20211—0398
202241360171
202334100333
20240—0425
20250—0835
20262—0—

What is it indicated for?

The Helix Hydro-Jet is intended for the cutting and dissection of soft tissue such as the liver, kidney, etc. within the abdomen, including Total Mesorectal Excision (TME), in open as well as laparoscopic surgery.

Indications for use as stated in the FDA summary.

Also cleared against K012464

2 other devices cite the same predicate.

  • K072404Erbe Erbejet 2 SystemErbe USA, Inc. · 2007
  • K021813Hydrocision General Surgery Fluidjet SystemHydrocision, Inc. · 2003

More from Erbe USA, Inc.

39 FDA decisions under this applicant name. See the company

  • K221177Erbe's Tubing/Cap SetsErbe USA, Inc. · 20221 recall
  • K191438ERBEFLO 2 Endo Quick Connect Pentax Scope Port ConnectorErbe USA, Inc. · 2019
  • K190469ERBEFLO 2 Disposable Tubing SystemErbe USA, Inc. · 20191 recall
  • K182444ERBEFLO Olympus Scope Port ConnectorErbe USA, Inc. · 2018
  • K162152Erbe’s CO2 Tubing/Cap SetsErbe USA, Inc. · 20161 recall

Recent decisions in FQH

The FQH category page

  • K253996BD Surgiphor™ Antimicrobial Irrigation System (910110)Becton, Dickinson and Company (BD) · 2026
  • K253445BD Surgiphor™ 1000 mL Antimicrobial Irrigation System (910120)Bd · 2026
  • K231023ERBEJET® 2 SystemErbe Elektromedizin GmbH · 2023
  • K220759Armis VeriCyn Wound WashArmis Biopharma, Inc. · 2023
  • K220964VERSAJET Hydrosurgery System (III)Smith & Nephew Medical Limited · 2023

https://510kreport.com/device/K022613 · printed Nov 6, 2026

Cite this page

510(k) Report. “K022613: 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/K022613

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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