510(k) · Cleared
Recalled · 2010Stryker Interpulse Handpiece Set, Splash Shields, Irrigation and Suction Tips, Rechargeable Battery Pack
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Instruments · FQH Lavage, Jet
Cleared on Jul 29, 1997 after a 56-day review. The FDA summary names its predicate without a number. 32 later devices descend from it. It has been recalled 7 times.
- Decided
- Jul 29, 1997
- Review
- 56 days
- Class
- Class II
- Product code
- FQH
- Recalls
- 7
- Predicates
- 0
32 later devices descend from it, 1 citing it directly.
- This deviceK972069 Stryker Interpulse Handpiece Set, Splash Shields, Irrigation and…Stryker Instruments · 1997
- Descendant · cites it directly · 31 of its ownK991383 Hydrocision Debdridement SystemHydrocision, Inc. · 2000
- Descendant · 2 generations on · 19 of its ownK012464 Helix Hydro-JetAndreas Pein Medizintechnik GmbH · 2001
- Descendant · 3 generations on · 17 of its ownK022613 Helix Hydro-JetErbe USA, Inc. · 2002
- Descendant · 4 generations on · 16 of its ownK033590 Erbe Helix Hydro-JetErbe USA, Inc. · 2004
- Descendant · 3 generations on · 14 of its ownK072404 Erbe Erbejet 2 SystemErbe USA, Inc. · 2007
Showing 5 of 32 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 32 · See all- K991383Hydrocision Debdridement SystemHydrocision, Inc. · 2000 · cites it directly31descendants
- K012464Helix Hydro-JetAndreas Pein Medizintechnik GmbH · 2001 · 2 generations on19descendants
- K022613Helix Hydro-JetErbe USA, Inc. · 2002 · 3 generations on17descendants
- K033590Erbe Helix Hydro-JetErbe USA, Inc. · 2004 · 4 generations on16descendants
- K072404Erbe Erbejet 2 SystemErbe USA, Inc. · 2007 · 3 generations on14descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K972069 | Stryker Interpulse Handpiece Set, Splash Shields, Irrigation and Suction Tips… | Stryker Instruments | 1997 | — |
| +1 | K991383 | Hydrocision Debdridement System | Hydrocision, Inc. | 2000 | — |
| +2 | K012464 | Helix Hydro-Jet | Andreas Pein Medizintechnik GmbH | 2001 | — |
| +3 | K022613 | Helix Hydro-Jet | Erbe USA, Inc. | 2002 | — |
| +4 | K033590 | Erbe Helix Hydro-Jet | Erbe USA, Inc. | 2004 | — |
| +3 | K072404 | Erbe Erbejet 2 System | Erbe USA, Inc. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 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? (2)
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 |
|---|---|---|---|
| * | — | Davol Named without a submission number | |
| * | — | Davis+Geck Named without a submission number |
What descends from it? (32)
See all 321 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K991383 | Hydrocision Debdridement System | 2000 | 31 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 4, 2010 | Not classified | Z-0950-2011 | Packaging process control | There is potential for a breach in sterility in the blister packaging. This can lead to the use of non-sterile product which, if contaminated, could lead to a patient infection. |
| Oct 4, 2010 | Not classified | Z-0947-2011 | Packaging process control | There is potential for a breach in sterility in the blister packaging. This can lead to the use of non-sterile product which, if contaminated, could lead to a patient infection. |
| Oct 4, 2010 | Not classified | Z-0948-2011 | Packaging process control | There is potential for a breach in sterility in the blister packaging. This can lead to the use of non-sterile product which, if contaminated, could lead to a patient infection. |
| Oct 4, 2010 | Not classified | Z-0949-2011 | Packaging process control | There is potential for a breach in sterility in the blister packaging. This can lead to the use of non-sterile product which, if contaminated, could lead to a patient infection. |
| Oct 4, 2010 | Not classified | Z-0953-2011 | Packaging process control | There is potential for a breach in sterility in the blister packaging. This can lead to the use of non-sterile product which, if contaminated, could lead to a patient infection. |
| Oct 4, 2010 | Not classified | Z-0951-2011 | Packaging process control | There is potential for a breach in sterility in the blister packaging. This can lead to the use of non-sterile product which, if contaminated, could lead to a patient infection. |
| Oct 4, 2010 | Not classified | Z-0952-2011 | Packaging process control | There is potential for a breach in sterility in the blister packaging. This can lead to the use of non-sterile product which, if contaminated, could lead to a patient infection. |
The 5 latest of 7 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K991383 (Hydrocision, Inc., 2000) has gone furthest, with 31 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 Stryker InterPulse Lavage System is intended for wound debridement, soft tissue debridement, and cleansing of a medical, clinical, or surgical site. This includes cleansing of bone in surgical procedures, hydrodebridement of chronic wounds, debridement of loose skin on burn wounds, and cleansing wounds incurred from trauma.
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/K972069 · printed Nov 4, 2026
Cite this page
510(k) Report. “K972069: Stryker Interpulse Handpiece Set, Splash Shields, Irrigation and Suction Tips, Rechargeable Battery Pack.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K972069
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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