510(k) · Cleared
ClearedMalis Irrigation Module 1000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Valley Forge Scientific Corp. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Nov 28, 2003 as substantially equivalent to K854413 (Valley Forge Scientific Corp., 1985) after a 23-day review. Its family tree reaches back 1 generation to 1985. 2 later devices descend from it.
- Decided
- Nov 28, 2003
- Review
- 23 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K854413 (1985). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK854413 Malis Irrigation SystemValley Forge Scientific Corp. · 1985
- This deviceK033499 Malis Irrigation Module 1000Valley Forge Scientific Corp. · 2003
- Descendant · cites it directly · 0 of its ownK200169 VFS1 Bipolar Electrosurgical GeneratorFHC, Inc. · 2020
- Descendant · cites it directly · 0 of its ownK182801 Codman Electrosurgical Irrigator, Codman Electrosurgical Irrigator…Integra LifeSciences Corporation · 2018
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K854413 | Malis Irrigation System | Valley Forge Scientific Corp. | 1985 | — |
| 0 (this device) | K033499 | Malis Irrigation Module 1000 | Valley Forge Scientific Corp. | 2003 | — |
| +1 | K200169 | VFS1 Bipolar Electrosurgical Generator | FHC, Inc. | 2020 | — |
| +1 | K182801 | Codman Electrosurgical Irrigator, Codman Electrosurgical Irrigator… | Integra LifeSciences Corporation | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2020 | 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 GEI? 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 GEI device
- #1 K231790 The InMode System with the Morpheus8 Applicatorsscore 32.7 · 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 |
|---|---|---|---|
| * | K854413 | Malis Irrigation SystemSummary page 1…Electrosurgical Cutting and Coagulation Device and Accessories Predicate Device: MALISTMIrrigation System (K854413) Intended Use: The MALISTMIrrigation Module 1000 is indicated for use with irrigat… | 1985 |
What descends from it? (2)
2 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?
- Its one ancestor has no recall.
- Of its descendants, K200169 (FHC, Inc., 2020) has gone furthest, with 0 descendants of its own.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GEI
52in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEI
113in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEI
4in 2025
Class I (14 since 2007) Class II/III not classified
Adverse event reports per year · GEI
7,592in 2025
MAUDE reports naming product code GEI, 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 | 50 | 51 | 21 | 2,795 |
| 2008 | 61 | 71 | 19 | 2,556 |
| 2009 | 42 | 130 | 27 | 3,591 |
| 2010 | 46 | 109 | 51 | 3,377 |
| 2011 | 35 | 135 | 32 | 4,463 |
| 2012 | 39 | 133 | 30 | 5,216 |
| 2013 | 48 | 136 | 13 | 4,897 |
| 2014 | 49 | 103 | 3 | 4,908 |
| 2015 | 47 | 123 | 4 | 4,936 |
| 2016 | 64 | 108 | 3 | 5,616 |
| 2017 | 52 | 72 | 2 | 6,073 |
| 2018 | 47 | 93 | 6 | 6,545 |
| 2019 | 48 | 93 | 5 | 7,067 |
| 2020 | 59 | 105 | 1 | 6,490 |
| 2021 | 46 | 146 | 6 | 6,354 |
| 2022 | 55 | 150 | 49 | 6,103 |
| 2023 | 65 | 104 | 27 (4) | 7,176 |
| 2024 | 59 | 125 | 22 (10) | 7,897 |
| 2025 | 52 | 113 | 4 | 7,592 |
| 2026 | 43 | 183 | 8 | — |
What is it indicated for?
The MALISTMIrrigation Module 1000 is indicated for use with imgating bipolar forceps with the CODMANB / MALISTMgenerators.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033499 · printed Nov 3, 2026
Cite this page
510(k) Report. “K033499: Malis Irrigation Module 1000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K033499
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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