510(k) Report

510(k) · Cleared

Cleared

Vision-Sciences Disposable Endosheath for Flexible Nasopharyngo-Laryngoscopes

K950809510(k) TraditionalCleared Aug 5, 1996530-day reviewClass II21 CFR 874.4760

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

Vision-Sciences, Inc. · EOB Nasopharyngoscope (Flexible Or Rigid)

Cleared on Aug 5, 1996 as substantially equivalent to K921244 (Vision-Sciences, Inc., 1992) and 2 other predicates after a 530-day review. Its family tree reaches back 1 generation to 1992. 184 later devices descend from it.

Decided
Aug 5, 1996
Review
530 days
Class
Class II
Product code
EOB
Recalls
None
Predicates
3

Its longest line of descent runs back 1 generation to K921244 (1992). 3 ancestors in all. 184 later devices descend from it, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1993: 2 other ancestors1996: 3 descendants cleared1999: 1 descendant cleared2006: 4 descendants cleared2002: 2 descendants cleared2003: 3 descendants cleared2004: 4 descendants cleared2005: 2 descendants cleared2010: 5 descendants cleared2009: 4 descendants cleared2007: 6 descendants cleared2008: 3 descendants cleared2012: 10 descendants cleared2011: 6 descendants cleared2016: 11 descendants cleared2022: 16 descendants cleared2020: 9 descendants cleared2015: 6 descendants cleared2017: 5 descendants cleared2026: 6 descendants cleared2018: 7 descendants cleared2013: 6 descendants cleared2014: 7 descendants cleared2019: 9 descendants cleared2021: 10 descendants cleared2023: 13 descendants cleared2024: 13 descendants cleared2025: 13 descendants clearedK921244 · Disposable Protective Sheath · Vision-Sciences, Inc. · 19921990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors 1 generation forward: 4 descendants2 generations forward: 12 descendants3 generations forward: 18 descendants4 generations forward: 33 descendants5 generations forward: 26 descendants6 generations forward: 15 descendants7 generations forward: 38 descendants8 generations forward: 25 descendants9 generations forward: 9 descendants10 generations forward: 3 descendants11 generations forward: 1 descendant K921244 · Disposable Protective Sheath · Vision-Sciences, Inc. · 19920+5+10
  1. Root · 1 generation backK921244 Disposable Protective SheathVision-Sciences, Inc. · 1992
  2. This deviceK950809 Vision-Sciences Disposable Endosheath for Flexible…Vision-Sciences, Inc. · 1996
  3. Descendant · cites it directly · 180 of its ownK990354 EndosheathVision-Sciences, Inc. · 1999
  4. Descendant · cites it directly · 158 of its ownK963795 Vision-Sciences Model B-F100 Bronchoscope with Model BS-F21…Vision-Sciences, Inc. · 1996
  5. Descendant · 2 generations on · 157 of its ownK012543 Vision Sciences Endosheath SystemVision-Sciences, Inc. · 2002
  6. Descendant · 2 generations on · 157 of its ownK021344 B-F200 Bronchoscope with BSS-F21 Endosheath SystemVision-Sciences, Inc. · 2002
  7. Descendant · 2 generations on · 92 of its ownK031786 Tne-2000 Esophagoscope with Ecs-D Endosheath SystemVision-Sciences, Inc. · 2003

Showing 5 of 184 descendants. See all descendants

Descendants cleared per year

1996: 31999: 12002: 22003: 32004: 42005: 22006: 42007: 62008: 32009: 42010: 52011: 62012: 102013: 62014: 72015: 62016: 112017: 52018: 72019: 92020: 92021: 102022: 162023: 132024: 132025: 132026: 6
1996high 16 (2022) · low 0 (1997)2026

Most influential descendants

Showing 5 of 184 · See all
  • K990354EndosheathVision-Sciences, Inc. · 1999 · cites it directly180descendants
  • K963795Vision-Sciences Model B-F100 Bronchoscope with Model BS-F21 Disposable EndosheathVision-Sciences, Inc. · 1996 · cites it directly158descendants
  • K012543Vision Sciences Endosheath SystemVision-Sciences, Inc. · 2002 · 2 generations on157descendants
  • K021344B-F200 Bronchoscope with BSS-F21 Endosheath SystemVision-Sciences, Inc. · 2002 · 2 generations on157descendants
  • K031786Tne-2000 Esophagoscope with Ecs-D Endosheath SystemVision-Sciences, Inc. · 2003 · 2 generations on92descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K921244Disposable Protective SheathVision-Sciences, Inc.1992—
0 (this device)K950809Vision-Sciences Disposable Endosheath for Flexible Nasopharyngo-LaryngoscopesVision-Sciences, Inc.1996—
+1K990354EndosheathVision-Sciences, Inc.1999—
+1K963795Vision-Sciences Model B-F100 Bronchoscope with Model BS-F21 Disposable…Vision-Sciences, Inc.1996—
+2K012543Vision Sciences Endosheath SystemVision-Sciences, Inc.2002—
+2K021344B-F200 Bronchoscope with BSS-F21 Endosheath SystemVision-Sciences, Inc.2002—
+2K031786Tne-2000 Esophagoscope with Ecs-D Endosheath SystemVision-Sciences, Inc.2003—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199320

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199630
199910
200220
200330
200440
200520
200640
200760
200830
200940
201050
201160
2012100
201360
201470
201560
2016110
201750
201870
201990
202090
2021100
2022160
2023130
2024130
2025130
202660
FIG. 1 — Lineage of K950809, 1992–2026Source: 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 EOB? 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 EOB device

  1. #1 K253184 Video Rhinolaryngoscope System (Disposable…score 14.4 · 12 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? (3)

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
*K921244Disposable Protective Sheath
Summary page 1
…R 874.4760). Predicate Devices: EndoSheaths for use with the Machida Model ENT-4L, Olympus Model ENF Type 3P, Pentax Model FNL-10S and Pentax Model FNL-13S endoscopes (K921244, K925421, K933247) Manufactured and Distributed by: Vision-Sciences, Inc. 6 Strathmore Rd. Natick, MA 01760 Product Descripti…
Vision-Sciences, Inc.1992—
*K925421Endosheath
Summary page 1
…0). Predicate Devices: EndoSheaths for use with the Machida Model ENT-4L, Olympus Model ENF Type 3P, Pentax Model FNL-10S and Pentax Model FNL-13S endoscopes (K921244, K925421, K933247) Manufactured and Distributed by: Vision-Sciences, Inc. 6 Strathmore Rd. Natick, MA 01760 Product Description: The…
Vision-Sciences, Inc.1993—
*K933247Protective Sheath for Flexible Nasophary/Larygnos
Summary page 1
…icate Devices: EndoSheaths for use with the Machida Model ENT-4L, Olympus Model ENF Type 3P, Pentax Model FNL-10S and Pentax Model FNL-13S endoscopes (K921244, K925421, K933247) Manufactured and Distributed by: Vision-Sciences, Inc. 6 Strathmore Rd. Natick, MA 01760 Product Description: The VSI EndoS…
Vision-Sciences, Inc.1993—

Also cleared against K921244: 3 other devices →

What descends from it? (184)

See all 184

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

NumberDeviceApplicantDecidedDescendants
K990354EndosheathVision-Sciences, Inc.1999180
K963795Vision-Sciences Model B-F100 Bronchoscope with Model BS-F21 Disposable EndosheathVision-Sciences, Inc.1996158
K963344Disposable SS-F32 Endosheath for Use with the S-F100 Flexible Fiberoptic SigmoidoscopeVision-Sciences, Inc.19962
K964100Vision-Sciences Model SS-U32 Endo Sheath for Use with the Vsi S-F100 Flexible Fiberoptic…Vision-Sciences, Inc.19960

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?

  • None of the 3 ancestors has a recall.
  • Of its descendants, K990354 (Vision-Sciences, Inc., 1999) has gone furthest, with 180 descendants of its own.
  • 3 other devices also cite its predicate K921244.

How does its category compare?

All EOB devices

EOB Nasopharyngoscope (Flexible Or Rigid): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · EOB

3in 2025

2007: 42008: 42009: 12010: 12011: 42012: 12014: 32015: 32016: 32017: 62018: 62019: 82020: 32021: 22022: 62023: 32024: 22025: 32026 (partial year): 5
2007high 8 (2019) · low 0 (2013)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · EOB

192in 2025

2007: 37 days median2008: 38 days median2011: 209 days median2014: 282 days median2015: 115 days median2016: 174 days median2017: 216 days median2018: 230 days median2019: 149 days median2020: 175 days median2022: 178 days median2023: 107 days median2025: 192 days median2026 (partial year): 180 days median
2007high 282 (2014) · low 37 (2007)2026

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

Recalls per year · EOB

1in 2023

2011: 22022: 12023: 12026 (partial year): 1
2007high 2 (2011) · low 0 (2007)2026

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

Adverse event reports per year · EOB

1,338in 2025

2007: 12008: 12009: 32011: 32012: 42013: 52014: 52015: 132016: 162017: 182018: 232019: 512020: 472021: 3452022: 1,1582023: 1,3522024: 1,4982025: 1,338
2007high 1,498 (2024) · low 0 (2010)2025

MAUDE reports naming product code EOB, 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
200743701
200843801
20091—03
20101—00
2011420923
20121—04
20130—05
2014328205
20153115013
20163174016
20176216018
20186230023
20198149051
20203175047
20212—0345
2022617811,158
2023310711,352
20242—01,498
2025319201,338
202651801—

What is it indicated for?

The EndoSheath provides a sterile, disposable protective covering for the scope to be used during endoscopic examination of the upper airway, vocal chords, and/or nasal passages.

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 K921244

3 other devices cite the same predicate.

  • K990354EndosheathVision-Sciences, Inc. · 1999
  • K964131EndoscopeAkos Biomedical, Inc. · 1997
  • K961591Disposable Endosheath for E-F100 Flexible NasopharyngoscopeVision-Sciences, Inc. · 1996

More from Vision-Sciences, Inc.

33 FDA decisions under this applicant name. See the company

  • K102733Vision-Sciences Ent-5000 Video Ent Scope with Endosheath Technology, Vision-Sciences Dpu-5000/Dpu-5050 Video…Vision-Sciences, Inc. · 2011
  • K100125Vision Sciences Flexible Ent ScopeVision-Sciences, Inc. · 20102 recalls
  • K091768Video Sciences BRS-5000 Video Bronchoscope with Endosheath System, Dpu-5000/Dpu-5050 Video Processor &…Vision-Sciences, Inc. · 2009
  • K072180Vision-Sciences CST-5000 Video Cystoscope with Endosheath SystemVision-Sciences, Inc. · 2007
  • K071127Flexible Hysteroscope with Endosheath SystemVision-Sciences, Inc. · 2007

Recent decisions in EOB

The EOB category page

  • K254299CLEARVISION Irrigation Sheath 0° (7241AS); CLEARVISION Irrigation Sheath 30° (7241BS); CLEARVISION…Karl Storz SE & CO. KG · 2026
  • K261544Hydro Irrigation SystemStryker Instruments · 2026
  • K254133ENTity USB Videoscope SystemOptim, LLC · 2026
  • K253184Video Rhinolaryngoscope System (Disposable Video Rhinolaryngoscope SP11A Endoscopic Video Processor M110B)Zhuhai Wesee Meditech Co., Ltd. · 2026
  • K252050Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241DOlympus Medical Systems Corporation · 2026

https://510kreport.com/device/K950809 · printed Nov 6, 2026

Cite this page

510(k) Report. “K950809: Vision-Sciences Disposable Endosheath for Flexible Nasopharyngo-Laryngoscopes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K950809

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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