510(k) · Cleared
ClearedHydrocision General Surgery Fluidjet System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hydrocision, Inc. · FQH Lavage, Jet
Cleared on May 9, 2003 as substantially equivalent to K011612 (Hydrocision, Inc., 2001) and 3 other predicates after a 340-day review. Its family tree reaches back 3 generations to 1997.
- Decided
- May 9, 2003
- Review
- 340 days
- Class
- Class II
- Product code
- FQH
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K972069 (1997). 12 ancestors in all, the oldest K832520 (1983). No later device cites it as a predicate yet.
- Root · 3 generations backK972069 Stryker Interpulse Handpiece Set, Splash Shields, Irrigation and…Stryker Instruments · 1997 · Recalled
- 2 generations backK991383 Hydrocision Debdridement SystemHydrocision, Inc. · 2000
- 1 generation backK011612 Modification to Hydrocision Debridement SystemHydrocision, Inc. · 2001
- This deviceK021813 Hydrocision General Surgery Fluidjet SystemHydrocision, Inc. · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K972069 | Stryker Interpulse Handpiece Set, Splash Shields, Irrigation and Suction Tips… | Stryker Instruments | 1997 | 7 |
| −2 | K991383 | Hydrocision Debdridement System | Hydrocision, Inc. | 2000 | — |
| −1 | K011612 | Modification to Hydrocision Debridement System | Hydrocision, Inc. | 2001 | — |
| 0 (this device) | K021813 | Hydrocision General Surgery Fluidjet System | Hydrocision, Inc. | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1985 | 1 | 0 |
| 1995 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 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? (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 |
|---|---|---|---|
| * | K011612 | Modification to Hydrocision Debridement System | 2001 |
| * | K992855 | XPS Straightshot or Model 2000 Microdebrider System or XPS PowersculptSummary page 1…rgery HuidJet System is substantially equivalent to the following devices: o Hydrocision Debridement System, KO1 1612 o . Xomed X P S Power Sculpt, K992855 o Andreas Pein, GMBH, Helix HydroJet, KO12464 o ValleyLab, Force 2 Electrosurgical Generator K844403… | 2000 |
| * | K012464 | Helix Hydro-Jet | 2001 |
| * | K844403 | Model Force 2 Electrosurgical GeneratorSummary page 1…stem, KO1 1612 o . Xomed X P S Power Sculpt, K992855 o Andreas Pein, GMBH, Helix HydroJet, KO12464 o ValleyLab, Force 2 Electrosurgical Generator K844403 Hydrocision, Inc 100 Burtt Road G01, Andover, MA 01810 Telephone (978)474-9300 Fax (978)474-5037ww… | 1985 |
What descends from it?
No later submission names this one as a predicate yet.
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 2 companies; a new generation was cleared every 1.9 years on median.
- 1 of the 12 ancestors has a recall of any class.
- 1 other device also cites its predicate K011612.
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 intended use of the Hydrocision General Surgery FluidJet System is for the tangential cutting, resection and removal of soft tissue or fluid from the body. Hydrocision General Surgery FluidJet System is not intended for use in suction lipoplasty procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021813 · printed Nov 4, 2026
Cite this page
510(k) Report. “K021813: Hydrocision General Surgery Fluidjet System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021813
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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