510(k) · Cleared
ClearedUnimax Suction Irrigation Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Unimax Medical Systems, Inc. · GCJ Laparoscope, General & Plastic Surgery
Cleared on May 19, 2011 as substantially equivalent to K041967 (Genicon, 2004) after a 171-day review. Its family tree reaches back 2 generations to 1997. 8 later devices descend from it.
- Decided
- May 19, 2011
- Review
- 171 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K963646 (1997). 8 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK963646 Stryker Strykeflow Suction Irrigator Gravity FlowStryker Endoscopy · 1997 · Recalled
- 1 generation backK041967 Genicon Suction Irrigation SystemGenicon · 2004
- This deviceK103509 Unimax Suction Irrigation SetUnimax Medical Systems, Inc. · 2011
- Descendant · cites it directly · 2 of its ownK192643 Dannik Laparoscopic Suction Irrigation SystemDannik · 2019
- Descendant · cites it directly · 2 of its ownK141592 Unimicro Suction Irriation Tubing SetUnimicro Medical Systems (Shenzhen) Co., Ltd. · 2014
- Descendant · 2 generations on · 1 of its ownK222575 HurriChem Device KitThermasolutions, LLC · 2022
- Descendant · cites it directly · 1 of its ownK150253 Disposable Suction Irrigation, 330mm, Disposable Suction Irrigation…Taiwan Surgical Corporation · 2015
- Descendant · 2 generations on · 0 of its ownK243867 LAGIS Suction Irrigation SystemLagis Enterprise Co., Ltd. · 2025
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K192643Dannik Laparoscopic Suction Irrigation SystemDannik · 2019 · cites it directly2descendants
- K141592Unimicro Suction Irriation Tubing SetUnimicro Medical Systems (Shenzhen) Co., Ltd. · 2014 · cites it directly2descendants
- K222575HurriChem Device KitThermasolutions, LLC · 2022 · 2 generations on1descendant
- K150253Disposable Suction Irrigation, 330mm, Disposable Suction Irrigation, 450mmTaiwan Surgical Corporation · 2015 · cites it directly1descendant
- K243867LAGIS Suction Irrigation SystemLagis Enterprise Co., Ltd. · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K963646 | Stryker Strykeflow Suction Irrigator Gravity Flow | Stryker Endoscopy | 1997 | 2 |
| −1 | K041967 | Genicon Suction Irrigation System | Genicon | 2004 | — |
| 0 (this device) | K103509 | Unimax Suction Irrigation Set | Unimax Medical Systems, Inc. | 2011 | — |
| +1 | K192643 | Dannik Laparoscopic Suction Irrigation System | Dannik | 2019 | — |
| +1 | K141592 | Unimicro Suction Irriation Tubing Set | Unimicro Medical Systems (Shenzhen) Co., Ltd. | 2014 | — |
| +2 | K222575 | HurriChem Device Kit | Thermasolutions, LLC | 2022 | — |
| +1 | K150253 | Disposable Suction Irrigation, 330mm, Disposable Suction Irrigation, 450mm | Taiwan Surgical Corporation | 2015 | — |
| +2 | K243867 | LAGIS Suction Irrigation System | Lagis Enterprise Co., Ltd. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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 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? (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 |
|---|---|---|---|
| * | K041967 | Genicon Suction Irrigation SystemSummary page 3…intended use, design, technology/principles of operation, materials and performance to the cleared GeniCon Laparoscopic Suction Irrigation which is the subject of K041967. Differences between the devices cited in this section do not raise any new issues of safety or effectiveness.… | 2004 |
What descends from it? (8)
3 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?
- The line of descent spans 14 years and passes through 3 companies; a new generation was cleared every 7.6 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K192643 (Dannik, 2019) has gone furthest, with 2 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. 2011, this device’s year, is highlighted.
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 | — |
What is it indicated for?
The Unimax Suction Irrigation Set is available with an array of probe designs to facilitate lavage during laparoscopic surgery. This device has applications in laparoscopic gynecologic, general, thoracic and urology procedures to provide suction and irrigation functions to help flush blood and tissue debris from the operative site during laparoscopy to aid visualization.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103509 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103509: Unimax Suction Irrigation Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103509
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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