510(k) Report

510(k) · Cleared

Cleared

Defendo (TM) Biopsy Valve for Olympus (R) and Fujinon (R) Endoscopes, Model 100301, Defendo (TM) Biopsy Valve for Pentax (R)

K090851510(k) TraditionalCleared Jul 2, 200994-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 Jul 2, 2009 after a 94-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 18 later devices descend from it.

Decided
Jul 2, 2009
Review
94 days
Class
Class II
Product code
ODC
Recalls
None
Predicates
0

18 later devices descend from it, 9 citing it directly.

Descendants, by year cleared 2019: 1 descendant cleared2024: 3 descendants cleared2020: 2 descendants cleared2021: 2 descendants cleared2011: 1 descendant cleared2022: 4 descendants cleared2023: 4 descendants cleared2025: 1 descendant cleared20052010201520202025
  1. This deviceK090851 Defendo (TM) Biopsy Valve for Olympus (R) and Fujinon (R)…Byrne Medical, Inc. · 2009
  2. Descendant · cites it directly · 7 of its ownK200769 Disposable Endoscope Valves Set, Disposable Endoscope Valves Set BWilson Instruments (Sha) Co., Ltd. · 2021
  3. Descendant · 2 generations on · 3 of its ownK220210 Disposable Endoscopy Adapter SetYangzhou Fartley Medical Instrument Technology Co., Ltd. · 2022
  4. Descendant · cites it directly · 2 of its ownK110088 Defendo Y-Opsy IrrigatorByrne Medical Incorporated · 2011
  5. Descendant · 2 generations on · 1 of its ownK220884 Disposable Endoscope Valve SetsSml Med-Tech Solutions Limited · 2023
  6. Descendant · cites it directly · 1 of its ownK210625 JAZZ Suction Valve, JAZZ Air/Water Valve, JAZZ Forceps ValveFujifilm Medwork GmbH · 2021

Showing 5 of 18 descendants. See all descendants

Descendants cleared per year

2011: 12019: 12020: 22021: 22022: 42023: 42024: 32025: 1
2011high 4 (2022) · low 0 (2012)2026

Most influential descendants

Showing 5 of 18 · See all
  • K200769Disposable Endoscope Valves Set, Disposable Endoscope Valves Set BWilson Instruments (Sha) Co., Ltd. · 2021 · cites it directly7descendants
  • K220210Disposable Endoscopy Adapter SetYangzhou Fartley Medical Instrument Technology Co., Ltd. · 2022 · 2 generations on3descendants
  • K110088Defendo Y-Opsy IrrigatorByrne Medical Incorporated · 2011 · cites it directly2descendants
  • K220884Disposable Endoscope Valve SetsSml Med-Tech Solutions Limited · 2023 · 2 generations on1descendant
  • K210625JAZZ Suction Valve, JAZZ Air/Water Valve, JAZZ Forceps ValveFujifilm Medwork GmbH · 2021 · cites it directly1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K090851Defendo (TM) Biopsy Valve for Olympus (R) and Fujinon (R) Endoscopes, Model…Byrne Medical, Inc.2009—
+1K200769Disposable Endoscope Valves Set, Disposable Endoscope Valves Set BWilson Instruments (Sha) Co., Ltd.2021—
+2K220210Disposable Endoscopy Adapter SetYangzhou Fartley Medical Instrument Technology Co., Ltd.2022—
+1K110088Defendo Y-Opsy IrrigatorByrne Medical Incorporated2011—
+2K220884Disposable Endoscope Valve SetsSml Med-Tech Solutions Limited2023—
+1K210625JAZZ Suction Valve, JAZZ Air/Water Valve, JAZZ Forceps ValveFujifilm Medwork GmbH2021—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201110
201910
202020
202120
202240
202340
202430
202510
FIG. 1 — Lineage of K090851, 2009–2025Source: 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 510(k) statement (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?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (18)

See all 18

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
K110088Defendo Y-Opsy IrrigatorByrne Medical Incorporated20112
K210625JAZZ Suction Valve, JAZZ Air/Water Valve, JAZZ Forceps ValveFujifilm Medwork GmbH20211
K200481Andorate Biopsy Valve, Andorate Biopsy IrrigatorGa Health Company Limited20201
K191231Andorate Auxiliary Water Connector, Andorate Valves SetSmartdata Suzhou Co., Ltd.20191
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
K221331Disposable Endoscope Valves SystemChangzhou Endoclean Medical Device Co., Ltd.20220
K192048Single Use Endoscope Valves SetAnrei Medical (Hangzhou) Co., Ltd.20200

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, K200769 (Wilson Instruments (Sha) Co., Ltd., 2021) has gone furthest, with 7 descendants of its own.

How does its category compare?

All ODC devices

ODC Endoscope Channel Accessory: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 DEFENDOTM Disposable Biopsy Valve is indicated for covering the endoscope biopsy port during an endoscopy procedure. The valve provides access for endoscopic device passage and exchange, helps maintain sufflation, and minimizes leakage of biomaterial from the biopsy port throughout the endoscopic procedure.

Indications for use as stated in the FDA 510(k) statement.

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 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/K090851 · printed Nov 5, 2026

Cite this page

510(k) Report. “K090851: Defendo (TM) Biopsy Valve for Olympus (R) and Fujinon (R) Endoscopes, Model 100301, Defendo (TM) Biopsy Valve for Pentax (R).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K090851

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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