510(k) · Cleared
ClearedModification to Hydrocision Debridement 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 Jun 22, 2001 as substantially equivalent to K991383 (Hydrocision, Inc., 2000) after a 28-day review. Its family tree reaches back 2 generations to 1997. 11 later devices descend from it.
- Decided
- Jun 22, 2001
- Review
- 28 days
- Class
- Class II
- Product code
- FQH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K972069 (1997). 3 ancestors in all. 11 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK972069 Stryker Interpulse Handpiece Set, Splash Shields, Irrigation and…Stryker Instruments · 1997 · Recalled
- 1 generation backK991383 Hydrocision Debdridement SystemHydrocision, Inc. · 2000
- This deviceK011612 Modification to Hydrocision Debridement SystemHydrocision, Inc. · 2001
- Descendant · cites it directly · 9 of its ownK060782 Versajet Hydrosurgery System and HandpieceSmith & Nephew Wound Management · 2006
- Descendant · 2 generations on · 5 of its ownK062544 AR1000 Ultrasonic Wound Therapy SystemArobella Medical, LLC · 2007 · Recalled
- Descendant · 3 generations on · 2 of its ownK112782 Misonix Sonicone (R) Ultrasonic Wound Care System and AccessoriesMisonix, Inc. · 2011
- Descendant · 2 generations on · 2 of its ownK110958 Versajet II Hydrosurgery System Console / Exact Handpieces / Plus…Smith & Nephew, Inc. · 2011
- Descendant · 3 generations on · 1 of its ownK143115 The VersaJet II Hydrosurgery SystemSmith & Nephew, Inc. · 2015
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K060782Versajet Hydrosurgery System and HandpieceSmith & Nephew Wound Management · 2006 · cites it directly9descendants
- K062544AR1000 Ultrasonic Wound Therapy SystemArobella Medical, LLC · 2007 · 2 generations on5descendants
- K112782Misonix Sonicone (R) Ultrasonic Wound Care System and AccessoriesMisonix, Inc. · 2011 · 3 generations on2descendants
- K110958Versajet II Hydrosurgery System Console / Exact Handpieces / Plus Handpieces, Versajet…Smith & Nephew, Inc. · 2011 · 2 generations on2descendants
- K143115The VersaJet II Hydrosurgery SystemSmith & Nephew, Inc. · 2015 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K972069 | Stryker Interpulse Handpiece Set, Splash Shields, Irrigation and Suction Tips… | Stryker Instruments | 1997 | 7 |
| −1 | K991383 | Hydrocision Debdridement System | Hydrocision, Inc. | 2000 | — |
| 0 (this device) | K011612 | Modification to Hydrocision Debridement System | Hydrocision, Inc. | 2001 | — |
| +1 | K060782 | Versajet Hydrosurgery System and Handpiece | Smith & Nephew Wound Management | 2006 | — |
| +2 | K062544 | AR1000 Ultrasonic Wound Therapy System | Arobella Medical, LLC | 2007 | 1 |
| +3 | K112782 | Misonix Sonicone (R) Ultrasonic Wound Care System and Accessories | Misonix, Inc. | 2011 | — |
| +2 | K110958 | Versajet II Hydrosurgery System Console / Exact Handpieces / Plus Handpieces… | Smith & Nephew, Inc. | 2011 | — |
| +3 | K143115 | The VersaJet II Hydrosurgery System | Smith & Nephew, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2023 | 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? (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 |
|---|---|---|---|
| * | K991383 | Hydrocision Debdridement SystemSummary page 1…tion of Legally Marketed Device The moditied HydroCision, Inc Debridement System is substantially equivalent in intended use to the HydroCision, Inc Debridement System (K991383). Device Description The HydroCision Debridement System uses a pressurized stream of sterile saline to lavage and clean wounds.… | 2000 |
What descends from it? (11)
See all 112 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 4 years and passes through 2 companies; a new generation was cleared every 2.7 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K060782 (Smith & Nephew Wound Management, 2006) has gone furthest, with 9 descendants of its own.
- 1 other device also cites its predicate K991383.
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 HydroCision, Inc. Debridement System is intended for wound debridement, soft tissue debridement, and cleansing of the surgical site in applications in which, in the physicians judgement, would require the use of a pulse lavage device with sharp debridement. This device is not intended to be used on burns.
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/K011612 · printed Nov 6, 2026
Cite this page
510(k) Report. “K011612: Modification to Hydrocision Debridement System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K011612
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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