510(k) · Cleared
Recalled · Class II · 2026Stryker Cassette Pump
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Endoscopy · GCX Apparatus, Suction, Operating-Room, Wall Vacuum Powered
Cleared on Dec 9, 2004 as substantially equivalent to K954726 (Stryker Endoscopy, 1995) and 1 other predicate after a 90-day review. Its family tree reaches back 1 generation to 1995. 4 later devices descend from it. It has been recalled 5 times.
- Decided
- Dec 9, 2004
- Review
- 90 days
- Class
- Class II
- Product code
- GCX
- Recalls
- 5
- Predicates
- 2
Its longest line of descent runs back 1 generation to K954726 (1995). 2 ancestors in all. 4 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK954726 Stryker Strykeflow Suction Irrigator (Modification)Stryker Endoscopy · 1995 · Recalled
- This deviceK042454 Stryker Cassette PumpStryker Endoscopy · 2004
- Descendant · cites it directly · 3 of its ownK122619 Epix Irrigation Pump, Epix Suction Irrigation Tubing SetApplied Medical · 2012
- Descendant · 2 generations on · 2 of its ownK180735 Endomat SelectKarl Storz SE & CO. KG · 2018
- Descendant · 3 generations on · 1 of its ownK201355 Endomat Select, IBS Shaver Software, LicenseKarl Storz SE & CO. KG · 2020
- Descendant · 4 generations on · 0 of its ownK261706 Endomat Select (UP220)Karl Storz SE & CO. KG · 2026
Most influential descendants
Showing 4 of 4 · See all- K122619Epix Irrigation Pump, Epix Suction Irrigation Tubing SetApplied Medical · 2012 · cites it directly3descendants
- K180735Endomat SelectKarl Storz SE & CO. KG · 2018 · 2 generations on2descendants
- K201355Endomat Select, IBS Shaver Software, LicenseKarl Storz SE & CO. KG · 2020 · 3 generations on1descendant
- K261706Endomat Select (UP220)Karl Storz SE & CO. KG · 2026 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K954726 | Stryker Strykeflow Suction Irrigator (Modification) | Stryker Endoscopy | 1995 | 22 |
| 0 (this device) | K042454 | Stryker Cassette Pump | Stryker Endoscopy | 2004 | — |
| +1 | K122619 | Epix Irrigation Pump, Epix Suction Irrigation Tubing Set | Applied Medical | 2012 | — |
| +2 | K180735 | Endomat Select | Karl Storz SE & CO. KG | 2018 | — |
| +3 | K201355 | Endomat Select, IBS Shaver Software, License | Karl Storz SE & CO. KG | 2020 | — |
| +4 | K261706 | Endomat Select (UP220) | Karl Storz SE & CO. KG | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2026 | 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 GCX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K954726 | Stryker Strykeflow Suction Irrigator (Modification)Summary page 1…Stryker Cassette Pump is substantially equivalent in terms of safety and effectiveness to currently® marketed devices including the Stryker Strykeflow Suction Irrigator (K954726) and the Davolo X-Streamm Laparoscopic Irrigation System (K003790). The Stryker Cassette Pump is a modification of the cu… | 1995 |
| * | K003790 | Davol X-Stream Laparoscopic Irrigation System, Models 5551000, 5552000, 5552001, 552002…Summary page 1…ty and effectiveness to currently® marketed devices including the Stryker Strykeflow Suction Irrigator (K954726) and the Davolo X-Streamm Laparoscopic Irrigation System (K003790). The Stryker Cassette Pump is a modification of the currently marketed Stryker Strykeflow Suction Irrigator in that the… | 2000 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K122619 | Epix Irrigation Pump, Epix Suction Irrigation Tubing Set | 2012 | 3 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 8, 2026 | Class II | Z-2864-2026 | Under Investigation by firm | There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use. |
| Jun 8, 2026 | Class II | Z-2862-2026 | Under Investigation by firm | There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use. |
| Jun 8, 2026 | Class II | Z-2863-2026 | Under Investigation by firm | There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use. |
| Nov 17, 2017 | Class II | Z-0836-2018 | Under Investigation by firm | Routine bioburden testing of certain lots were found to have levels higher than internal acceptable rates. |
| Nov 18, 2005 | Not classified | Z-0279-06 | Other | Devices for which sterility may be compromised as evidenced by a crack in the package. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All GCX devicesGCX Apparatus, Suction, Operating-Room, Wall Vacuum Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GCX
FDA has decided no GCX device since 2007.
Median 510(k) review, days · GCX
Too few GCX 510(k)s in any year since 2007 to give a median.
Recalls per year · GCX
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GCX
274in 2025
MAUDE reports naming product code GCX, 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 | 0 | — | 0 | 24 |
| 2008 | 0 | — | 0 | 44 |
| 2009 | 0 | — | 0 | 40 |
| 2010 | 0 | — | 0 | 51 |
| 2011 | 0 | — | 0 | 67 |
| 2012 | 0 | — | 0 | 242 |
| 2013 | 0 | — | 1 | 47 |
| 2014 | 0 | — | 0 | 32 |
| 2015 | 0 | — | 0 | 52 |
| 2016 | 0 | — | 0 | 99 |
| 2017 | 0 | — | 1 | 45 |
| 2018 | 0 | — | 0 | 50 |
| 2019 | 0 | — | 0 | 65 |
| 2020 | 0 | — | 0 | 65 |
| 2021 | 0 | — | 0 | 65 |
| 2022 | 0 | — | 0 | 72 |
| 2023 | 0 | — | 3 | 59 |
| 2024 | 0 | — | 1 | 65 |
| 2025 | 0 | — | 0 | 274 |
| 2026 | 0 | — | 3 | — |
What is it indicated for?
The Stryker Cassette Pump Is intended as a general purpose suction and/or irrigation device for use in laparoscopic and open general surgery, laparoscopic and open gynecological surgery, laparoscopic and open urologic surgery, endoscopic and open nasal surgery, open otolaryncologic surgery, and open plastic surgery. This device provides sterile irrigant solution, serves as a conduit for suction, and functions as a cannula for accessory instrumentation, including electrosurgical devices.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042454 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042454: Stryker Cassette Pump.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042454
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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