510(k) · Cleared
ClearedHelix Hydro-Jet
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Andreas Pein Medizintechnik GmbH · FQH Lavage, Jet
Cleared on Oct 10, 2001 as substantially equivalent to K982266 (Hydrocision, Inc., 1998) and 3 other predicates after a 70-day review. Its family tree reaches back 2 generations to 1995. 19 later devices descend from it.
- Decided
- Oct 10, 2001
- Review
- 70 days
- Class
- Class II
- Product code
- FQH
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K952726 (1995). 6 ancestors in all. 19 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK952726 Ultracision Harmonic ScapelUltracision, Inc. · 1995
- 1 generation backK990430 Ultracision Harmonic Scalpel Hand PieceEthicon Endo-Surgery, Inc. · 1999
- This deviceK012464 Helix Hydro-JetAndreas Pein Medizintechnik GmbH · 2001
- Descendant · cites it directly · 17 of its ownK022613 Helix Hydro-JetErbe USA, Inc. · 2002
- Descendant · 2 generations on · 16 of its ownK033590 Erbe Helix Hydro-JetErbe USA, Inc. · 2004
- Descendant · cites it directly · 14 of its ownK072404 Erbe Erbejet 2 SystemErbe USA, Inc. · 2007
- Descendant · 3 generations on · 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
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · See all- K022613Helix Hydro-JetErbe USA, Inc. · 2002 · cites it directly17descendants
- K033590Erbe Helix Hydro-JetErbe USA, Inc. · 2004 · 2 generations on16descendants
- 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 · 3 generations on14descendants
- K083608Erbe Hybrid KnifeErbe USA, Inc. · 2009 · 2 generations on13descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K952726 | Ultracision Harmonic Scapel | Ultracision, Inc. | 1995 | — |
| −1 | K990430 | Ultracision Harmonic Scalpel Hand Piece | Ethicon Endo-Surgery, Inc. | 1999 | — |
| 0 (this device) | K012464 | Helix Hydro-Jet | Andreas Pein Medizintechnik GmbH | 2001 | — |
| +1 | K022613 | Helix Hydro-Jet | Erbe USA, Inc. | 2002 | — |
| +2 | K033590 | Erbe Helix Hydro-Jet | Erbe USA, Inc. | 2004 | — |
| +1 | K072404 | Erbe Erbejet 2 System | Erbe USA, Inc. | 2007 | — |
| +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 | — |
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 |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 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? (4)
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 |
|---|---|---|---|
| * | K982266 | Hydrocision Arthrojet SystemSummary page 2…= 510(k) Number: K012464 Page 2 of 2 Comparison to Predicate Devices The following prior legally marketed devices have been used to establish substantial equivalence: K982266 HydroCision Arthroscopic Cutting System HydroCision, Inc. K991383 HydroCision Inc. Debridement System HydroCision, Inc. K993564 P… | 1998 |
| * | K991383 | Hydrocision Debdridement SystemSummary page 2…ces The following prior legally marketed devices have been used to establish substantial equivalence: K982266 HydroCision Arthroscopic Cutting System HydroCision, Inc. K991383 HydroCision Inc. Debridement System HydroCision, Inc. K993564 Possis AngioJet Xpeedior Catheter Possis Medical, Inc. K990430 Ultr… | 2000 |
| * | K993564 | Possis Angiojet X-Stream Rheolytic Thrombectomy Catheter, Model 103587-002Summary page 2…ed to establish substantial equivalence: K982266 HydroCision Arthroscopic Cutting System HydroCision, Inc. K991383 HydroCision Inc. Debridement System HydroCision, Inc. K993564 Possis AngioJet Xpeedior Catheter Possis Medical, Inc. K990430 Ultracision Harmonic Scalpel Hand Piece Ethicon Endo-Surgery, Inc… | 2000 |
| * | K990430 | Ultracision Harmonic Scalpel Hand PieceSummary page 2…rthroscopic Cutting System HydroCision, Inc. K991383 HydroCision Inc. Debridement System HydroCision, Inc. K993564 Possis AngioJet Xpeedior Catheter Possis Medical, Inc. K990430 Ultracision Harmonic Scalpel Hand Piece Ethicon Endo-Surgery, Inc. Non-Clinical Testing The requirements of the following stan… | 1999 |
What descends from it? (19)
See all 193 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 6 years and passes through 3 companies; a new generation was cleared every 3.7 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K022613 (Erbe USA, Inc., 2002) has gone furthest, with 17 descendants of its own.
- 3 other devices also cite its predicate K982266.
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 cutting and dissection of soft tissue such as liver and kidney in open abdominal surgery.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K012464 · printed Nov 4, 2026
Cite this page
510(k) Report. “K012464: Helix Hydro-Jet.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K012464
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026