510(k) · Cleared
ClearedPrecision Endoscopic Infrared Coagulator; Model 5100 Single- Use Disposable Maxi-Guide Flexible Lightguide; Model 5100-2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Max Endoscopy, Inc. · KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Cleared on Jun 9, 2009 after a 215-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 2 later devices descend from it.
- Decided
- Jun 9, 2009
- Review
- 215 days
- Class
- Class II
- Product code
- KNS
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 2 citing it directly.
- This deviceK083275 Precision Endoscopic Infrared Coagulator; Model 5100 Single- Use…Max Endoscopy, Inc. · 2009
- Descendant · cites it directly · 1 of its ownK122593 Precision Endoscopic Infrared Coagulator; Model 5100 Single-Use…Optim, LLC · 2012
- Descendant · cites it directly · 0 of its ownK130489 Electrode, Flexible Suction CoagulatorOptim, LLC · 2013
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 |
|---|---|---|---|---|---|
| 0 (this device) | K083275 | Precision Endoscopic Infrared Coagulator; Model 5100 Single- Use Disposable… | Max Endoscopy, Inc. | 2009 | — |
| +1 | K122593 | Precision Endoscopic Infrared Coagulator; Model 5100 Single-Use Disposable… | Optim, LLC | 2012 | — |
| +1 | K130489 | Electrode, Flexible Suction Coagulator | Optim, LLC | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KNS? 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 KNS device
- #1 K241271 Aqua Medical RF Vapor Ablation Systemscore 17.2 · 20 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’s file for it is a 510(k) statement, which names no predicate.
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?
- Of its descendants, K122593 (Optim, LLC, 2012) has gone furthest, with 1 descendant of its own.
How does its category compare?
All KNS devicesKNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · KNS
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KNS
171in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KNS
14in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KNS
1,504in 2025
MAUDE reports naming product code KNS, 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 | 1 | — | 3 | 164 |
| 2008 | 3 | 61 | 5 | 587 |
| 2009 | 3 | 212 | 2 | 1,027 |
| 2010 | 4 | 168 | 0 | 908 |
| 2011 | 1 | — | 2 | 860 |
| 2012 | 2 | — | 0 | 848 |
| 2013 | 2 | — | 0 | 449 |
| 2014 | 1 | — | 0 | 405 |
| 2015 | 3 | 252 | 0 | 406 |
| 2016 | 3 | 30 | 6 | 457 |
| 2017 | 3 | 48 | 1 | 446 |
| 2018 | 5 | 62 | 0 | 563 |
| 2019 | 7 | 66 | 0 | 668 |
| 2020 | 4 | 212 | 0 | 906 |
| 2021 | 4 | 139 | 41 | 814 |
| 2022 | 3 | 182 | 0 | 913 |
| 2023 | 9 | 83 | 0 | 976 |
| 2024 | 3 | 198 | 14 | 1,533 |
| 2025 | 11 | 171 | 0 | 1,504 |
| 2026 | 2 | — | 4 | — |
What is it indicated for?
The PRECISION Endoscopic Infrared Coagulator (model 5100) with single-use disposable MAXi-guide flexible light guide (model 5100-240-3.2) is intended for treatment of hemorrhoids by the transmission of infrared energy when used as an accessory to a colonoscope, flexible sigmoidoscope, or other flexible gastrointestinal endoscope.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K083275 · printed Nov 4, 2026
Cite this page
510(k) Report. “K083275: Precision Endoscopic Infrared Coagulator; Model 5100 Single- Use Disposable Maxi-Guide Flexible Lightguide; Model 5100-2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K083275
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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