510(k) · Cleared
Recalled · Class II · 2022Davol X-Stream Laparoscopic Irrigation System, Models 5551000, 5552000, 5552001, 552002, 5552003, 5552004, 5552005
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Davol, Inc. · GCJ Laparoscope, General & Plastic Surgery
Cleared on Dec 22, 2000 after a 14-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it. It has been recalled once.
- Decided
- Dec 22, 2000
- Review
- 14 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- 1
- Predicates
- 0
5 later devices descend from it, 1 citing it directly.
- This deviceK003790 Davol X-Stream Laparoscopic Irrigation System, Models 5551000…Davol, Inc. · 2000
- Descendant · cites it directly · 4 of its ownK042454 Stryker Cassette PumpStryker Endoscopy · 2004 · Recalled
- Descendant · 2 generations on · 3 of its ownK122619 Epix Irrigation Pump, Epix Suction Irrigation Tubing SetApplied Medical · 2012
- Descendant · 3 generations on · 2 of its ownK180735 Endomat SelectKarl Storz SE & CO. KG · 2018
- Descendant · 4 generations on · 1 of its ownK201355 Endomat Select, IBS Shaver Software, LicenseKarl Storz SE & CO. KG · 2020
- Descendant · 5 generations on · 0 of its ownK261706 Endomat Select (UP220)Karl Storz SE & CO. KG · 2026
Most influential descendants
Showing 5 of 5 · See all- K042454Stryker Cassette PumpStryker Endoscopy · 2004 · cites it directly4descendants
- K122619Epix Irrigation Pump, Epix Suction Irrigation Tubing SetApplied Medical · 2012 · 2 generations on3descendants
- K180735Endomat SelectKarl Storz SE & CO. KG · 2018 · 3 generations on2descendants
- K201355Endomat Select, IBS Shaver Software, LicenseKarl Storz SE & CO. KG · 2020 · 4 generations on1descendant
- K261706Endomat Select (UP220)Karl Storz SE & CO. KG · 2026 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K003790 | Davol X-Stream Laparoscopic Irrigation System, Models 5551000, 5552000… | Davol, Inc. | 2000 | — |
| +1 | K042454 | Stryker Cassette Pump | Stryker Endoscopy | 2004 | 5 |
| +2 | K122619 | Epix Irrigation Pump, Epix Suction Irrigation Tubing Set | Applied Medical | 2012 | — |
| +3 | K180735 | Endomat Select | Karl Storz SE & CO. KG | 2018 | — |
| +4 | K201355 | Endomat Select, IBS Shaver Software, License | Karl Storz SE & CO. KG | 2020 | — |
| +5 | K261706 | Endomat Select (UP220) | Karl Storz SE & CO. KG | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2012 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GCJ? 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 GCJ device
- #1 K214046 780 nm 1688 4K Camera System, 780 nm L11 LED…score 21.4 · 21 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K042454 | Stryker Cassette Pump | 2004 | 4 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 27, 2022 | Class II | Z-1457-2022 | Under Investigation by firm | The device may potentially cause a fire, leading to a safety risk. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K042454 (Stryker Endoscopy, 2004) has gone furthest, with 4 descendants of its own.
How does its category compare?
All GCJ devicesGCJ Laparoscope, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GCJ
21in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GCJ
108in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GCJ
5in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GCJ
5,860in 2025
MAUDE reports naming product code GCJ, 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 | 18 | 42 | 12 | 1,639 |
| 2008 | 19 | 73 | 16 | 1,319 |
| 2009 | 21 | 85 | 6 | 1,995 |
| 2010 | 24 | 122 | 30 | 2,657 |
| 2011 | 15 | 113 | 9 | 2,133 |
| 2012 | 17 | 88 | 1 | 1,526 |
| 2013 | 15 | 93 | 7 (1) | 1,565 |
| 2014 | 19 | 90 | 2 | 1,714 |
| 2015 | 26 | 76 | 0 | 1,710 |
| 2016 | 27 | 99 | 5 | 2,080 |
| 2017 | 20 | 77 | 1 | 3,468 |
| 2018 | 21 | 88 | 1 | 2,562 |
| 2019 | 15 | 60 | 0 | 2,578 |
| 2020 | 28 | 61 | 0 | 2,618 |
| 2021 | 18 | 116 | 0 | 3,431 |
| 2022 | 20 | 103 | 1 | 3,945 |
| 2023 | 31 | 109 | 1 | 6,002 |
| 2024 | 29 | 90 | 0 | 6,047 |
| 2025 | 21 | 108 | 5 | 5,860 |
| 2026 | 26 | 122 | 1 | — |
https://510kreport.com/device/K003790 · printed Nov 6, 2026
Cite this page
510(k) Report. “K003790: Davol X-Stream Laparoscopic Irrigation System, Models 5551000, 5552000, 5552001, 552002, 5552003, 5552004, 5552005.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K003790
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026