510(k) · Cleared

Cleared

Precision Endoscopic Infrared Coagulator; Model 5100 Single-Use Disposable Maxi-Guide Flexible Lightguide; Model 5100-2

K122593510(k) SpecialCleared Sep 13, 201220-day reviewClass II21 CFR 876.4300

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Optim, LLC · FEH Electrode, Flexible Suction Coagulator

Cleared on Sep 13, 2012 as substantially equivalent to K083275 (Max Endoscopy, Inc., 2009) after a 20-day review. Its family tree reaches back 1 generation to 2009. 1 later device descends from it.

Decided: Sep 13, 2012
Review: 20 days
Class: Class II
Product code: FEH
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K083275 (2009). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK083275 Precision Endoscopic Infrared Coagulator; Model 5100 Single- Use…Max Endoscopy, Inc. · 2009
This deviceK122593 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 1 of 1 · See all

K130489Electrode, Flexible Suction CoagulatorOptim, LLC · 2013 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K083275	Precision Endoscopic Infrared Coagulator; Model 5100 Single- Use Disposable…	Max Endoscopy, Inc.	2009	—
0 (this device)	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
2013	1	0

FIG. 1 — Lineage of K122593, 2009–2013Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	K083275	Precision Endoscopic Infrared Coagulator; Model 5100 Single- Use Disposable Maxi-Guide… Summary page 1 …terology / Urology Predicate Device Information Precision Endloscopic Infrared Coagulator; Model 5100 Single-Use disposable Maxi-guide Flexible Uightguide; Model 5100-2 (K083275) Submission Device Description: This device isdesigned to coagulate blood and tissue, specifically for treatment of hemorrhoids…	Max Endoscopy, Inc.	2009	—

Also cleared against K083275: 1 other device →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K130489	Electrode, Flexible Suction Coagulator	Optim, LLC	2013	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, K130489 (Optim, LLC, 2013) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate K083275.

How does its category compare?

All FEH devices

FEH Electrode, Flexible Suction Coagulator: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.

FDA decisions per year · FEH

1in 2013

2007high 1 (2012) · low 0 (2007)2026

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

2007high 2 (2007) · low 0 (2008)2025

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	MAUDE reports
2007	0	—	2
2008	0	—	0
2009	0	—	0
2010	0	—	0
2011	0	—	0
2012	1	—	0
2013	1	—	1
2014	0	—	0
2015	0	—	0
2016	0	—	0
2017	0	—	2
2018	0	—	1
2019	0	—	0
2020	0	—	1
2021	0	—	1
2022	0	—	0
2023	0	—	0
2024	0	—	0
2025	0	—	0
2026	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 endoscope.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K122593 · printed Nov 6, 2026

Cite this page

510(k) Report. “K122593: 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 6, 2026. https://510kreport.com/device/K122593

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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