510(k) Report

510(k) · Cleared

Cleared

Meditron Endolav Model EL-100

K882048510(k) TraditionalCleared Oct 31, 1988168-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

Xylog Corp. · KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)

Cleared on Oct 31, 1988 after a 168-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 13 later devices descend from it.

Decided
Oct 31, 1988
Review
168 days
Class
Class II
Product code
KNS
Recalls
None
Predicates
0

13 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2006: 1 descendant cleared2012: 3 descendants cleared2007: 1 descendant cleared2021: 1 descendant cleared2009: 1 descendant cleared2014: 1 descendant cleared2016: 3 descendants cleared2020: 1 descendant cleared2018: 1 descendant cleared1990200020102020
  1. This deviceK882048 Meditron Endolav Model EL-100Xylog Corp. · 1988
  2. Descendant · cites it directly · 12 of its ownK060962 Endogator Endoscopy Irrigation Pump, Model Egp-100Byrne Medical, Inc. · 2006
  3. Descendant · 2 generations on · 6 of its ownK100624 Invendo C20 Colonoscopy SystemInvendo Medical Gbmh · 2012
  4. Descendant · 3 generations on · 5 of its ownK121582 Invendo C25 Colonoscopy SystemInvendo Medical Gbmh · 2012
  5. Descendant · 3 generations on · 2 of its ownK141286 Aer-O-Scope Colonoscope SystemGi View, Ltd. · 2014
  6. Descendant · 2 generations on · 2 of its ownK113119 Endogator Advantage Irrigation PumpByrne Medical, Inc. · 2012

Showing 5 of 13 descendants. See all descendants

Descendants cleared per year

2006: 12007: 12009: 12012: 32014: 12016: 32018: 12020: 12021: 1
2006high 3 (2012) · low 0 (2008)2026

Most influential descendants

Showing 5 of 13 · See all
  • K060962Endogator Endoscopy Irrigation Pump, Model Egp-100Byrne Medical, Inc. · 2006 · cites it directly12descendants
  • K100624Invendo C20 Colonoscopy SystemInvendo Medical Gbmh · 2012 · 2 generations on6descendants
  • K121582Invendo C25 Colonoscopy SystemInvendo Medical Gbmh · 2012 · 3 generations on5descendants
  • K141286Aer-O-Scope Colonoscope SystemGi View, Ltd. · 2014 · 3 generations on2descendants
  • K113119Endogator Advantage Irrigation PumpByrne Medical, Inc. · 2012 · 2 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K882048Meditron Endolav Model EL-100Xylog Corp.1988—
+1K060962Endogator Endoscopy Irrigation Pump, Model Egp-100Byrne Medical, Inc.2006—
+2K100624Invendo C20 Colonoscopy SystemInvendo Medical Gbmh2012—
+3K121582Invendo C25 Colonoscopy SystemInvendo Medical Gbmh2012—
+3K141286Aer-O-Scope Colonoscope SystemGi View, Ltd.2014—
+2K113119Endogator Advantage Irrigation PumpByrne Medical, Inc.2012—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
200710
200910
201230
201410
201630
201810
202010
202110
FIG. 1 — Lineage of K882048, 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), 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. #1 K241271 Aqua Medical RF Vapor Ablation Systemscore 17.2 · 20 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (13)

See all 13

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

NumberDeviceApplicantDecidedDescendants
K060962Endogator Endoscopy Irrigation Pump, Model Egp-100Byrne Medical, Inc.200612

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, K060962 (Byrne Medical, Inc., 2006) has gone furthest, with 12 descendants of its own.

How does its category compare?

All KNS devices

KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KNS

11in 2025

2007: 12008: 32009: 32010: 42011: 12012: 22013: 22014: 12015: 32016: 32017: 32018: 52019: 72020: 42021: 42022: 32023: 92024: 32025: 112026 (partial year): 2
2007high 11 (2025) · low 1 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KNS

171in 2025

2008: 61 days median2009: 212 days median2010: 168 days median2015: 252 days median2016: 30 days median2017: 48 days median2018: 62 days median2019: 66 days median2020: 212 days median2021: 139 days median2022: 182 days median2023: 83 days median2024: 198 days median2025: 171 days median
2007high 252 (2015) · low 30 (2016)2026

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

Recalls per year · KNS

14in 2024

2007: 32008: 52009: 22011: 22016: 62017: 12021: 412024: 142026 (partial year): 4
2007high 41 (2021) · low 0 (2010)2026

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

Adverse event reports per year · KNS

1,504in 2025

2007: 1642008: 5872009: 1,0272010: 9082011: 8602012: 8482013: 4492014: 4052015: 4062016: 4572017: 4462018: 5632019: 6682020: 9062021: 8142022: 9132023: 9762024: 1,5332025: 1,504
2007high 1,533 (2024) · low 164 (2007)2025

MAUDE reports naming product code KNS, 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
20071—3164
20083615587
2009321221,027
201041680908
20111—2860
20122—0848
20132—0449
20141—0405
201532520406
20163306457
20173481446
20185620563
20197660668
202042120906
2021413941814
202231820913
20239830976
20243198141,533
20251117101,504
20262—4—
Cite this page

510(k) Report. “K882048: Meditron Endolav Model EL-100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K882048

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026