510(k) · Cleared
ClearedElectrode, Flexible Suction Coagulator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Optim, LLC · FEH Electrode, Flexible Suction Coagulator
Cleared on Apr 19, 2013 as substantially equivalent to K122593 (Optim, LLC, 2012) and 1 other predicate after a 53-day review. Its family tree reaches back 2 generations to 2009.
- Decided
- Apr 19, 2013
- Review
- 53 days
- Class
- Class II
- Product code
- FEH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K083275 (2009). No later device cites it as a predicate yet.
- Root · 2 generations backK083275 Precision Endoscopic Infrared Coagulator; Model 5100 Single- Use…Max Endoscopy, Inc. · 2009
- 1 generation backK122593 Precision Endoscopic Infrared Coagulator; Model 5100 Single-Use…Optim, LLC · 2012
- This deviceK130489 Electrode, Flexible Suction CoagulatorOptim, LLC · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | 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 | — |
| 0 (this device) | K130489 | Electrode, Flexible Suction Coagulator | Optim, LLC | 2013 | — |
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 FEH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K122593 | Precision Endoscopic Infrared Coagulator; Model 5100 Single-Use Disposable Maxi-Guide…Summary page 1…ogy Predicate Device Information " Precision Endloscopic Infrared Coagulator; Model 5100 Single-Use disposable Maxi-guide Flexible Lightguide; Model 5100-2 (K122593); Precision Endloscopic Technologies, Inc. " Precision Endoscopic Infrared Coagulator; Model 5100 Single-Use disposable Maxi-… | 2012 |
| * | K083275 | Precision Endoscopic Infrared Coagulator; Model 5100 Single- Use Disposable Maxi-Guide…Summary page 1…on Endloscopic Technologies, Inc. " Precision Endoscopic Infrared Coagulator; Model 5100 Single-Use disposable Maxi-guide Flexible Lightguide; Model 5100-2 (K083275); MAX Endloscopy, Inc. Submission Device Description: This device is designed to coagulate blood and tissue, specifically for tr… | 2009 |
What descends from it?
No later submission names this one as a predicate yet.
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 4 years and passes through 2 companies; a new generation was cleared every 3.3 years on median.
- None of the 2 ancestors has a recall.
How does its category compare?
All FEH devicesFEH Electrode, Flexible Suction Coagulator: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · FEH
1in 2013
2026 to Oct 25, outlined.
Median 510(k) review, days · FEH
Too few FEH 510(k)s in any year since 2007 to give a median.
Recalls per year · FEH
No recall names FEH since 2007.
Adverse event reports per year · FEH
1in 2021
MAUDE reports naming product code FEH, 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 | 0 | — | 0 | 2 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The PRECISION Endloscopic Infrared Coagulator with single-use disposable MAXiguide flexible light guide is intended for treatment of hemorrhoids and other lesions in the colon and rectum by the transmission of infrared energy when used as an accessory to a colonoscope, flexible sigmoidloscope, or other flexible gastrointestinal endloscope.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130489 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130489: Electrode, Flexible Suction Coagulator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130489
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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