510(k) · Cleared
ClearedMalis 2000 Bipolar Electrosurgical System
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 Mar 9, 2005 as substantially equivalent to K955346 (Valley Forge Scientific Corp., 1995) after a 23-day review. Its family tree reaches back 1 generation to 1995. 1 later device descends from it.
- Decided
- Mar 9, 2005
- Review
- 23 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K955346 (1995). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK955346 VFS - 300 Bipolar Electrosurgery SystemValley Forge Scientific Corp. · 1995
- This deviceK050364 Malis 2000 Bipolar Electrosurgical SystemValley Forge Scientific Corp. · 2005
- Descendant · cites it directly · 0 of its ownK200169 VFS1 Bipolar Electrosurgical GeneratorFHC, Inc. · 2020
Most influential descendants
Showing 1 of 1 · See all- K200169VFS1 Bipolar Electrosurgical GeneratorFHC, Inc. · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K955346 | VFS - 300 Bipolar Electrosurgery System | Valley Forge Scientific Corp. | 1995 | — |
| 0 (this device) | K050364 | Malis 2000 Bipolar Electrosurgical System | Valley Forge Scientific Corp. | 2005 | — |
| +1 | K200169 | VFS1 Bipolar Electrosurgical Generator | FHC, Inc. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K955346 | VFS - 300 Bipolar Electrosurgery SystemSummary page 1…de namne Mallis Bipolar 2000 Electrosurgical System Classification: Electro Surgical Device Predicate Device: K955346, VFS 300 Classification: Class II Performance Standard: Pursuant to Section 1990 CFR 870.92, no… | 1995 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K200169 | VFS1 Bipolar Electrosurgical Generator | 2020 | 0 |
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 MALLS 2000 Bipolar Electrosurgical system is indicated for use in micro, macro and endoscopic bipolar cutting and coagulation of tissue and sealing of blood vessels in all types of surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050364 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050364: Malis 2000 Bipolar Electrosurgical System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050364
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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