510(k) · Cleared
ClearedHydrocision Debdridement 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 Mar 31, 2000 as substantially equivalent to K972069 (Stryker Instruments, 1997) and 1 other predicate after a 345-day review. Its family tree reaches back 1 generation to 1997. 31 later devices descend from it.
- Decided
- Mar 31, 2000
- Review
- 345 days
- Class
- Class II
- Product code
- FQH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K972069 (1997). 2 ancestors in all. 31 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK972069 Stryker Interpulse Handpiece Set, Splash Shields, Irrigation and…Stryker Instruments · 1997 · Recalled
- This deviceK991383 Hydrocision Debdridement SystemHydrocision, Inc. · 2000
- Descendant · cites it directly · 19 of its ownK012464 Helix Hydro-JetAndreas Pein Medizintechnik GmbH · 2001
- Descendant · 2 generations on · 17 of its ownK022613 Helix Hydro-JetErbe USA, Inc. · 2002
- Descendant · 3 generations on · 16 of its ownK033590 Erbe Helix Hydro-JetErbe USA, Inc. · 2004
- Descendant · 2 generations on · 14 of its ownK072404 Erbe Erbejet 2 SystemErbe USA, Inc. · 2007
- Descendant · 4 generations on · 14 of its ownK062712 Erbe Monopolar Attachment for Helix Hydro-Jet, Model P/N 20139-094Erbe USA, Inc. · 2007
Showing 5 of 31 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 31 · See all- K012464Helix Hydro-JetAndreas Pein Medizintechnik GmbH · 2001 · cites it directly19descendants
- K022613Helix Hydro-JetErbe USA, Inc. · 2002 · 2 generations on17descendants
- K033590Erbe Helix Hydro-JetErbe USA, Inc. · 2004 · 3 generations on16descendants
- K072404Erbe Erbejet 2 SystemErbe USA, Inc. · 2007 · 2 generations on14descendants
- K062712Erbe Monopolar Attachment for Helix Hydro-Jet, Model P/N 20139-094Erbe USA, Inc. · 2007 · 4 generations on14descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K972069 | Stryker Interpulse Handpiece Set, Splash Shields, Irrigation and Suction Tips… | Stryker Instruments | 1997 | 7 |
| 0 (this device) | K991383 | Hydrocision Debdridement System | Hydrocision, Inc. | 2000 | — |
| +1 | K012464 | Helix Hydro-Jet | Andreas Pein Medizintechnik GmbH | 2001 | — |
| +2 | K022613 | Helix Hydro-Jet | Erbe USA, Inc. | 2002 | — |
| +3 | K033590 | Erbe Helix Hydro-Jet | Erbe USA, Inc. | 2004 | — |
| +2 | K072404 | Erbe Erbejet 2 System | Erbe USA, Inc. | 2007 | — |
| +4 | K062712 | Erbe Monopolar Attachment for Helix Hydro-Jet, Model P/N 20139-094 | Erbe USA, Inc. | 2007 | — |
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 |
|---|---|---|
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 3 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2011 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 3 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 3 | 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? (3)
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 |
|---|---|---|---|
| * | K972069 | Stryker Interpulse Handpiece Set, Splash Shields, Irrigation and Suction Tips…Summary page 1…f Legally Marketed Device The HydroCision, Inc Debridement System is substantially equivalent in intended use to the Stryker Corporation Interpulse Pulse Lavage System (K972069) in combination with sharp debridement. The intended use is also the same as the Zimmer Pulsavac Wound Debridement System in comb… | 1997 |
| * | K982266 | Hydrocision Arthrojet SystemSummary page 1…dement System in combination with sharp debridement. It is also substantially equivalent in design, materials and construction to its own ArthroJet System cleared under K982266. 4. Device Description The HydroCision Debridement System uses pressurized streams of sterile saline to lavage and clean wounds… | 1998 |
| * | — | Zimmer Pulsavac Wound Debridement System Named without a submission number |
What descends from it? (31)
See all 312 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?
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K012464 (Andreas Pein Medizintechnik GmbH, 2001) has gone furthest, with 19 descendants of its own.
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/K991383 · printed Nov 4, 2026
Cite this page
510(k) Report. “K991383: Hydrocision Debdridement System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K991383
Report an extraction error
Are you the manufacturer?
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