510(k) · Cleared
ClearedVERSAJET Hydrosurgery System (III)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew Medical Limited · FQH Lavage, Jet
Cleared on May 16, 2023 as substantially equivalent to K143115 (Smith & Nephew, Inc., 2015) after a 410-day review. Its family tree reaches back 6 generations to 1997.
- Decided
- May 16, 2023
- Review
- 410 days
- Class
- Class II
- Product code
- FQH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K972069 (1997). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK972069 Stryker Interpulse Handpiece Set, Splash Shields, Irrigation and…Stryker Instruments · 1997 · Recalled
- 5 generations backK991383 Hydrocision Debdridement SystemHydrocision, Inc. · 2000
- 4 generations backK011612 Modification to Hydrocision Debridement SystemHydrocision, Inc. · 2001
- 3 generations backK060782 Versajet Hydrosurgery System and HandpieceSmith & Nephew Wound Management · 2006
- 2 generations backK110958 Versajet II Hydrosurgery System Console / Exact Handpieces / Plus…Smith & Nephew, Inc. · 2011
- 1 generation backK143115 The VersaJet II Hydrosurgery SystemSmith & Nephew, Inc. · 2015
- This deviceK220964 VERSAJET Hydrosurgery System (III)Smith & Nephew Medical Limited · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K972069 | Stryker Interpulse Handpiece Set, Splash Shields, Irrigation and Suction Tips… | Stryker Instruments | 1997 | 7 |
| −5 | K991383 | Hydrocision Debdridement System | Hydrocision, Inc. | 2000 | — |
| −4 | K011612 | Modification to Hydrocision Debridement System | Hydrocision, Inc. | 2001 | — |
| −3 | K060782 | Versajet Hydrosurgery System and Handpiece | Smith & Nephew Wound Management | 2006 | — |
| −2 | K110958 | Versajet II Hydrosurgery System Console / Exact Handpieces / Plus Handpieces… | Smith & Nephew, Inc. | 2011 | — |
| −1 | K143115 | The VersaJet II Hydrosurgery System | Smith & Nephew, Inc. | 2015 | — |
| 0 (this device) | K220964 | VERSAJET Hydrosurgery System (III) | Smith & Nephew Medical Limited | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 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 |
|---|---|---|---|
| * | K143115 | The VersaJet II Hydrosurgery SystemSummary page 4…Number Regulatory Class Class II Product Code FQH 21 CFR 807.92 (a)(3): Legally 510(k) Number: K143115 marketed device to Device Name: VERSAJET II Hydrosurgery System which equivalence is claimed… | 2015 |
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 26 years and passes through 5 companies; a new generation was cleared every 4.8 years on median.
- 1 of the 7 ancestors has a recall of any class.
How does its category compare?
All FQH devicesFQH Lavage, Jet: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
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 VERSAJET III Hydrosurgery System cuts, ablates and removes tissue and foreign matter from wounds via
pressurized saline. The system is intended for applications that in the physician’s judgment, require sharp debridement:
- wound debridement (acute and chronic wounds, burns),
- soft tissue debridement and cleansing of surgical sites.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K220964 · printed Nov 4, 2026
Cite this page
510(k) Report. “K220964: VERSAJET Hydrosurgery System (III).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K220964
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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