510(k) Report

510(k) · Cleared

Cleared

Endogator Endoscopy Irrigation Pump, Model Egp-100

K060962510(k) TraditionalCleared Apr 19, 200612-day reviewClass II21 CFR 876.1500

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

Byrne Medical, Inc. · OCX Endoscopic Irrigation/Suction System

Cleared on Apr 19, 2006 as substantially equivalent to K882048 (Xylog Corp., 1988) after a 12-day review. Its family tree reaches back 1 generation to 1988. 12 later devices descend from it.

Decided
Apr 19, 2006
Review
12 days
Class
Class II
Product code
OCX
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K882048 (1988). 12 later devices descend from it, 5 citing it directly.

Descendants, by year cleared 2012: 3 descendants cleared2007: 1 descendant cleared2021: 1 descendant cleared2009: 1 descendant cleared2014: 1 descendant cleared2016: 3 descendants cleared2020: 1 descendant cleared2018: 1 descendant clearedK882048 · Meditron Endolav Model EL-100 · Xylog Corp. · 19881990200020102020
Descendants, by generation 1 generation forward: 5 descendants2 generations forward: 5 descendants3 generations forward: 2 descendants K882048 · Meditron Endolav Model EL-100 · Xylog Corp. · 19880
  1. Root · 1 generation backK882048 Meditron Endolav Model EL-100Xylog Corp. · 1988
  2. This deviceK060962 Endogator Endoscopy Irrigation Pump, Model Egp-100Byrne Medical, Inc. · 2006
  3. Descendant · cites it directly · 6 of its ownK100624 Invendo C20 Colonoscopy SystemInvendo Medical Gbmh · 2012
  4. Descendant · 2 generations on · 5 of its ownK121582 Invendo C25 Colonoscopy SystemInvendo Medical Gbmh · 2012
  5. Descendant · 2 generations on · 2 of its ownK141286 Aer-O-Scope Colonoscope SystemGi View, Ltd. · 2014
  6. Descendant · cites it directly · 2 of its ownK113119 Endogator Advantage Irrigation PumpByrne Medical, Inc. · 2012
  7. Descendant · 2 generations on · 1 of its ownK161355 invendoscopy E200 SystemInvendo Medical GmbH · 2016

Showing 5 of 12 descendants. See all descendants

Descendants cleared per year

2007: 12009: 12012: 32014: 12016: 32018: 12020: 12021: 1
2007high 3 (2012) · low 0 (2008)2026

Most influential descendants

Showing 5 of 12 · See all
  • K100624Invendo C20 Colonoscopy SystemInvendo Medical Gbmh · 2012 · cites it directly6descendants
  • K121582Invendo C25 Colonoscopy SystemInvendo Medical Gbmh · 2012 · 2 generations on5descendants
  • K141286Aer-O-Scope Colonoscope SystemGi View, Ltd. · 2014 · 2 generations on2descendants
  • K113119Endogator Advantage Irrigation PumpByrne Medical, Inc. · 2012 · cites it directly2descendants
  • K161355invendoscopy E200 SystemInvendo Medical GmbH · 2016 · 2 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K882048Meditron Endolav Model EL-100Xylog Corp.1988—
0 (this device)K060962Endogator Endoscopy Irrigation Pump, Model Egp-100Byrne Medical, Inc.2006—
+1K100624Invendo C20 Colonoscopy SystemInvendo Medical Gbmh2012—
+2K121582Invendo C25 Colonoscopy SystemInvendo Medical Gbmh2012—
+2K141286Aer-O-Scope Colonoscope SystemGi View, Ltd.2014—
+1K113119Endogator Advantage Irrigation PumpByrne Medical, Inc.2012—
+2K161355invendoscopy E200 SystemInvendo Medical GmbH2016—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
200910
201230
201410
201630
201810
202010
202110
FIG. 1 — Lineage of K060962, 1988–2021Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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 OCX? 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 OCX device

  1. #1 K251986 Auxiliary Water Tube Maj-855score 12.8 · 10 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin 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.

TypeNumberDeviceApplicantDecidedRecalls
*K882048Meditron Endolav Model EL-100
Summary page 1
…: Endoscopy Irrigation Pump Classification Name: Enidoscope and/or Accessonies 3. Predicate Devices: Meditron Endolav Mode! EL-lOG, K882048, Xylog Corp.. 83 Hobart St. Hackensack. NJ 07601 4. Classifications Narmes & Citations: 21 CFR 876.1500, Class II,…
Xylog Corp.1988—

What descends from it? (12)

See all 12

5 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K100624Invendo C20 Colonoscopy SystemInvendo Medical Gbmh20126
K113119Endogator Advantage Irrigation PumpByrne Medical, Inc.20122
K210618Beamer Aveo Irrigation Pump, Endolinq Endoscopic Irrigation Pump, Endoscopic Irrigation…Chongqing Jinshan Science & Technology Co., Ltd.20210
K092461Irrigation Pump, Irrigation Biopsy Valve, ,Model 00711520, 00711139, 00711140United States Endoscopy Group, Inc.20090
K063700Spyglass Irrigation SystemMedical Scientific, Inc.20070

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, K100624 (Invendo Medical Gbmh, 2012) has gone furthest, with 6 descendants of its own.

How does its category compare?

All OCX devices

OCX Endoscopic Irrigation/Suction System: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · OCX

4in 2025

2009: 12010: 32011: 12012: 42013: 32014: 62015: 22016: 22018: 52019: 82020: 42021: 32022: 62023: 72024: 42025: 4
2007high 8 (2019) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OCX

178in 2025

2010: 51 days median2012: 256 days median2013: 106 days median2014: 77 days median2018: 60 days median2019: 133 days median2020: 88 days median2021: 233 days median2022: 84 days median2023: 109 days median2024: 74 days median2025: 178 days median
2007high 256 (2012) · low 51 (2010)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · OCX

2in 2022

2015: 12020: 112022: 22026 (partial year): 2
2007high 11 (2020) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · OCX

33in 2025

2008: 12012: 12013: 12014: 52015: 92016: 82017: 92018: 182019: 412020: 112021: 82022: 182023: 462024: 212025: 33
2007high 46 (2023) · low 0 (2007)2025

MAUDE reports naming product code OCX, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—01
20091—00
201035100
20111—00
2012425601
2013310601
201467705
20152—19
20162—08
20170—09
2018560018
20198133041
20204881111
2021323308
2022684218
20237109046
2024474021
20254178033
20260—2—

What is it indicated for?

Endoscopic irrigation for use with washing catheters integral endoscope water jet channels and endoscope working channels.

Indications for use as stated in the FDA summary.

More from Byrne Medical, Inc.

12 FDA decisions under this applicant name. See the company

  • K113310Endogater Avantage CO2 InsufflatorByrne Medical, Inc. · 2012
  • K113119Endogator Advantage Irrigation PumpByrne Medical, Inc. · 2012
  • K102855Universal Irrigation Solution HybridByrne Medical, Inc. · 2010
  • K102581Defendo Disposable Suction Valve Model 100305Byrne Medical, Inc. · 2010
  • K102409Defendo Disposable Air/Water Valve Model 100304Byrne Medical, Inc. · 2010

Recent decisions in OCX

The OCX category page

  • K251986Auxiliary Water Tube Maj-855Olympus Medical Systems Corporation · 2025
  • K251997Single-Use Biopsy Valve (MAJ-1555)Olympus Medical Systems Corporation · 2025
  • K242586ArgoCap (200.52)Ovesco Endoscopy AG · 2025
  • K241704Endoscopic Water PumpHangzhou AGS MedTech Co., Ltd. · 2025
  • K242357Water Container (MAJ-901); Water Container (MAJ-902)Olympus Medical Systems Corporation · 2024

https://510kreport.com/device/K060962 · printed Nov 4, 2026

Cite this page

510(k) Report. “K060962: Endogator Endoscopy Irrigation Pump, Model Egp-100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060962

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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