510(k) Report

510(k) · Cleared

Cleared

Defendo Disposable Suction Valve Model 100305

K102581510(k) TraditionalCleared Nov 8, 201061-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. · ODC Endoscope Channel Accessory

Cleared on Nov 8, 2010 as substantially equivalent to K001241 (The Olympus Optical Co., 2000) after a 61-day review. Its family tree reaches back 1 generation to 2000. 22 later devices descend from it.

Decided
Nov 8, 2010
Review
61 days
Class
Class II
Product code
ODC
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K001241 (2000). 22 later devices descend from it, 9 citing it directly.

Descendants, by year cleared 2023: 4 descendants cleared2016: 1 descendant cleared2019: 1 descendant cleared2024: 5 descendants cleared2020: 1 descendant cleared2021: 2 descendants cleared2015: 1 descendant cleared2025: 3 descendants cleared2022: 4 descendants clearedK001241 · Evis Exera Colonovideoscope CF-Q160 AL/I and PCF-160 AL/I · The Olympus Optical Co. · 2000 · recalled200020052010201520202025
Descendants, by generation 1 generation forward: 9 descendants2 generations forward: 8 descendants3 generations forward: 5 descendants K001241 · Evis Exera Colonovideoscope CF-Q160 AL/I and PCF-160 AL/I · The Olympus Optical Co. · 2000 · recalled0
  1. Root · 1 generation backK001241 Evis Exera Colonovideoscope CF-Q160 AL/I and PCF-160 AL/IThe Olympus Optical Co. · 2000 · Recalled
  2. This deviceK102581 Defendo Disposable Suction Valve Model 100305Byrne Medical, Inc. · 2010
  3. Descendant · cites it directly · 7 of its ownK200769 Disposable Endoscope Valves Set, Disposable Endoscope Valves Set BWilson Instruments (Sha) Co., Ltd. · 2021
  4. Descendant · cites it directly · 3 of its ownK232329 Defendo Fujifilm 700 Single Use Biopsy Valve; Defendo Fujifilm 700…Medivators (A Subsidiary of Steris Corporation) · 2023
  5. Descendant · 2 generations on · 3 of its ownK220210 Disposable Endoscopy Adapter SetYangzhou Fartley Medical Instrument Technology Co., Ltd. · 2022
  6. Descendant · 2 generations on · 1 of its ownK240352 Defendo Single Use Cleaning Adapter for Olympus EndoscopesSTERIS Corporation · 2024
  7. Descendant · 2 generations on · 1 of its ownK220884 Disposable Endoscope Valve SetsSml Med-Tech Solutions Limited · 2023

Showing 5 of 22 descendants. See all descendants

Descendants cleared per year

2015: 12016: 12019: 12020: 12021: 22022: 42023: 42024: 52025: 3
2015high 5 (2024) · low 0 (2017)2026

Most influential descendants

Showing 5 of 22 · See all
  • K200769Disposable Endoscope Valves Set, Disposable Endoscope Valves Set BWilson Instruments (Sha) Co., Ltd. · 2021 · cites it directly7descendants
  • K232329Defendo Fujifilm 700 Single Use Biopsy Valve; Defendo Fujifilm 700 Single Use Air/Water…Medivators (A Subsidiary of Steris Corporation) · 2023 · cites it directly3descendants
  • K220210Disposable Endoscopy Adapter SetYangzhou Fartley Medical Instrument Technology Co., Ltd. · 2022 · 2 generations on3descendants
  • K240352Defendo Single Use Cleaning Adapter for Olympus EndoscopesSTERIS Corporation · 2024 · 2 generations on1descendant
  • K220884Disposable Endoscope Valve SetsSml Med-Tech Solutions Limited · 2023 · 2 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K001241Evis Exera Colonovideoscope CF-Q160 AL/I and PCF-160 AL/IThe Olympus Optical Co.20001
0 (this device)K102581Defendo Disposable Suction Valve Model 100305Byrne Medical, Inc.2010—
+1K200769Disposable Endoscope Valves Set, Disposable Endoscope Valves Set BWilson Instruments (Sha) Co., Ltd.2021—
+1K232329Defendo Fujifilm 700 Single Use Biopsy Valve; Defendo Fujifilm 700 Single Use…Medivators (A Subsidiary of Steris Corporation)2023—
+2K220210Disposable Endoscopy Adapter SetYangzhou Fartley Medical Instrument Technology Co., Ltd.2022—
+2K240352Defendo Single Use Cleaning Adapter for Olympus EndoscopesSTERIS Corporation2024—
+2K220884Disposable Endoscope Valve SetsSml Med-Tech Solutions Limited2023—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201510
201610
201910
202010
202120
202240
202340
202450
202530
FIG. 1 — Lineage of K102581, 2000–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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 ODC? 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 ODC device

  1. #1 K232329 Defendo Fujifilm 700 Single Use Biopsy Valve…score 14.0 · 6 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

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
*K001241Evis Exera Colonovideoscope CF-Q160 AL/I and PCF-160 AL/I
Summary page 5
…, Texas 77303 Summary of Safety and Effectiveness Data The Byrne Medical, Inc., DEFENDO™ Dispaosable Suction Valve and predicate device (Olympus® MH-443 Suction Valve, K001241) are in Class II, 21 CFR 876.1500 with Advisory Commuttee of Gastroenterology/Urology. The predicate device Olympus® - Suction V…
The Olympus Optical Co.20001

Also cleared against K001241: 14 other devices →

What descends from it? (22)

See all 22

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

NumberDeviceApplicantDecidedDescendants
K200769Disposable Endoscope Valves Set, Disposable Endoscope Valves Set BWilson Instruments (Sha) Co., Ltd.20217
K232329Defendo Fujifilm 700 Single Use Biopsy Valve; Defendo Fujifilm 700 Single Use Air/Water…Medivators (A Subsidiary of Steris Corporation)20233
K210625JAZZ Suction Valve, JAZZ Air/Water Valve, JAZZ Forceps ValveFujifilm Medwork GmbH20211
K191231Andorate Auxiliary Water Connector, Andorate Valves SetSmartdata Suzhou Co., Ltd.20191
K160403SmartStart Air/Water and Suction ValvesEndochoice, Inc.20161
K232067Defendo Fujifilm 500/600 Single Use Air/Water Valve, Defendo Fujifilm 500/600 Single Use…Medivators (A Subsidiary of Steris Corporation)20240
K232004Defendo Pentax Single Use Biopsy Valve, Defendo Pentax Single Use Air/Water Valve…Medivators (A Subsidiary of Steris Corporation)20240
K192048Single Use Endoscope Valves SetAnrei Medical (Hangzhou) Co., Ltd.20200
K151522DEFENDO Bronchoscopy Suction ValveMedivators, Inc.20150

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 a recall.
  • Of its descendants, K200769 (Wilson Instruments (Sha) Co., Ltd., 2021) has gone furthest, with 7 descendants of its own.
  • 14 other devices also cite its predicate K001241.

How does its category compare?

All ODC devices

ODC Endoscope Channel Accessory: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.

FDA decisions per year · ODC

6in 2025

2008: 32009: 12010: 42011: 42012: 22015: 22016: 12017: 12018: 22019: 42020: 42021: 62022: 82023: 72024: 82025: 62026 (partial year): 1
2007high 8 (2022) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · ODC

106in 2025

2008: 83 days median2010: 67 days median2011: 143 days median2019: 55 days median2020: 128 days median2021: 181 days median2022: 118 days median2023: 126 days median2024: 95 days median2025: 106 days median
2007high 181 (2021) · low 55 (2019)2026

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

Recalls per year · ODC

1so far in 2026, the most since 2007

2026 (partial year): 1
2007high 1 (2026) · low 0 (2007)2026

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

Adverse event reports per year · ODC

91in 2025

2012: 12013: 12014: 22015: 32016: 82017: 122018: 172019: 402020: 542021: 522022: 372023: 432024: 1002025: 91
2007high 100 (2024) · low 0 (2007)2025

MAUDE reports naming product code ODC, 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
200838300
20091—00
201046700
2011414300
20122—01
20130—01
20140—02
20152—03
20161—08
20171—012
20182—017
2019455040
20204128054
20216181052
20228118037
20237126043
20248950100
20256106091
20261—1—

What is it indicated for?

The DEFENDO™ Disposable Suction Valve is intended to be used to control the suction

function on an endoscope during a Gl endoscopic procedure.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K001241

14 other devices cite the same predicate.

  • K190669EndoticsEra Endoscopy S.R.L. · 2020
  • K151714Disposable Endoscope Valves Set AWilson Instruments (Shanghai) Company Limited · 2015
  • K131855Pentax Video Colonoscopes (EC Family)Pentax Medical Company · 20146 recalls
  • K100624Invendo C20 Colonoscopy SystemInvendo Medical Gbmh · 2012
  • K102409Defendo Disposable Air/Water Valve Model 100304Byrne Medical, Inc. · 2010
  • K070622Neoguide Endoscopy SystemNeoguide Systems, Inc. · 2007

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
  • K102409Defendo Disposable Air/Water Valve Model 100304Byrne Medical, Inc. · 2010
  • K093665Endo SmartcapByrne Medical, Inc. · 20097 recalls

Recent decisions in ODC

The ODC category page

  • K252933Dyne PortDyne Medical Group, Inc. · 2026
  • K250145Biopsy Port AdapterEndosound, Inc. · 2025
  • K252910Orca Air/Water and Suction ValvesBoston Scientific · 20251 recall
  • K250949Suction Valve (MAJ-1443); Air/Water Valve (MAJ-1444)Olympus Medical Systems Corporation · 20252 recalls
  • K250732Disposable Endoscopy Valve SetYangzhou Fartley Medical Instrument Technology Co., Ltd. · 2025

https://510kreport.com/device/K102581 · printed Nov 6, 2026

Cite this page

510(k) Report. “K102581: Defendo Disposable Suction Valve Model 100305.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102581

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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