510(k) · Cleared
ClearedCadman Integrated Irrigation Tubing and Bipolar Cord Set, Models 80-1163, 80-1189
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Codman & Shurtleff, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Oct 17, 2005 after a 41-day review. The FDA summary names its predicate without a number. 5 later devices descend from it.
- Decided
- Oct 17, 2005
- Review
- 41 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 3 citing it directly.
- This deviceK052449 Cadman Integrated Irrigation Tubing and Bipolar Cord Set, Models…Codman & Shurtleff, Inc. · 2005
- Descendant · cites it directly · 1 of its ownK211170 Single Use Irrigation bipolar cableModern Medical Equipment Manufacturing, Ltd. · 2021
- Descendant · cites it directly · 1 of its ownK163106 CODMAN Integrated Bipolar Cord and Tubing SetMedos International SARL · 2016
- Descendant · 2 generations on · 0 of its ownK251492 Irrigation Tubing Bipolar Cord SetNew Deantronics Taiwan, Ltd. · 2026
- Descendant · 2 generations on · 0 of its ownK180908 Irrigation Tubing Bipolar Cord SetNew Deantronics Taiwan, Ltd. · 2018
- Descendant · cites it directly · 0 of its ownK072937 Olsen Medical Integrated Irrigation Tubing and Bipolar Cord SetOlsen Medical · 2007
Most influential descendants
Showing 5 of 5 · See all- K211170Single Use Irrigation bipolar cableModern Medical Equipment Manufacturing, Ltd. · 2021 · cites it directly1descendant
- K163106CODMAN Integrated Bipolar Cord and Tubing SetMedos International SARL · 2016 · cites it directly1descendant
- K251492Irrigation Tubing Bipolar Cord SetNew Deantronics Taiwan, Ltd. · 2026 · 2 generations on0descendants
- K180908Irrigation Tubing Bipolar Cord SetNew Deantronics Taiwan, Ltd. · 2018 · 2 generations on0descendants
- K072937Olsen Medical Integrated Irrigation Tubing and Bipolar Cord SetOlsen Medical · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K052449 | Cadman Integrated Irrigation Tubing and Bipolar Cord Set, Models 80-1163… | Codman & Shurtleff, Inc. | 2005 | — |
| +1 | K211170 | Single Use Irrigation bipolar cable | Modern Medical Equipment Manufacturing, Ltd. | 2021 | — |
| +1 | K163106 | CODMAN Integrated Bipolar Cord and Tubing Set | Medos International SARL | 2016 | — |
| +2 | K251492 | Irrigation Tubing Bipolar Cord Set | New Deantronics Taiwan, Ltd. | 2026 | — |
| +2 | K180908 | Irrigation Tubing Bipolar Cord Set | New Deantronics Taiwan, Ltd. | 2018 | — |
| +1 | K072937 | Olsen Medical Integrated Irrigation Tubing and Bipolar Cord Set | Olsen Medical | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 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 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 |
|---|---|---|---|
| * | — | Codman/Malis Integrated Irrigation Tubing and Bipolar Cord Set Named without a submission number |
What descends from it? (5)
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?
- Of its descendants, K211170 (Modern Medical Equipment Manufacturing, Ltd., 2021) has gone furthest, with 1 descendant 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 Codman Integrated Irrigation Tubing and Bipolar Cord Sets are intended to provide irrigation and energy simultaneously to bipolar forceps specifically designed for irrigation.
They are intended for use with the Codman/Malis CMC®-II and the Codman/Malis CMC® III I.E.C. Irrigation Modules and the Codman/Malis Bipolar Coagulators.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052449 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052449: Cadman Integrated Irrigation Tubing and Bipolar Cord Set, Models 80-1163, 80-1189.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052449
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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