510(k) · Cleared

Cleared

Disposable Endosheath for E-F100 Flexible Nasopharyngoscope

K961591510(k) TraditionalCleared Jul 2, 199669-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 Jul 2, 1996 as substantially equivalent to K921244 (Vision-Sciences, Inc., 1992) and 2 other predicates after a 69-day review. Its family tree reaches back 1 generation to 1992. 184 later devices descend from it.

Decided: Jul 2, 1996
Review: 69 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.

By dateBy generation

Root · 1 generation backK921244 Disposable Protective SheathVision-Sciences, Inc. · 1992
This deviceK961591 Disposable Endosheath for E-F100 Flexible NasopharyngoscopeVision-Sciences, Inc. · 1996
Descendant · cites it directly · 180 of its ownK990354 EndosheathVision-Sciences, Inc. · 1999
Descendant · cites it directly · 158 of its ownK963795 Vision-Sciences Model B-F100 Bronchoscope with Model BS-F21…Vision-Sciences, Inc. · 1996
Descendant · 2 generations on · 157 of its ownK012543 Vision Sciences Endosheath SystemVision-Sciences, Inc. · 2002
Descendant · 2 generations on · 157 of its ownK021344 B-F200 Bronchoscope with BSS-F21 Endosheath SystemVision-Sciences, Inc. · 2002
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

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

Generation	Number	Device	Applicant	Decided	Recalls
−1	K921244	Disposable Protective Sheath	Vision-Sciences, Inc.	1992	—
0 (this device)	K961591	Disposable Endosheath for E-F100 Flexible Nasopharyngoscope	Vision-Sciences, Inc.	1996	—
+1	K990354	Endosheath	Vision-Sciences, Inc.	1999	—
+1	K963795	Vision-Sciences Model B-F100 Bronchoscope with Model BS-F21 Disposable…	Vision-Sciences, Inc.	1996	—
+2	K012543	Vision Sciences Endosheath System	Vision-Sciences, Inc.	2002	—
+2	K021344	B-F200 Bronchoscope with BSS-F21 Endosheath System	Vision-Sciences, Inc.	2002	—
+2	K031786	Tne-2000 Esophagoscope with Ecs-D Endosheath System	Vision-Sciences, Inc.	2003	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1993	2	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1996	3	0
1999	1	0
2002	2	0
2003	3	0
2004	4	0
2005	2	0
2006	4	0
2007	6	0
2008	3	0
2009	4	0
2010	5	0
2011	6	0
2012	10	0
2013	6	0
2014	7	0
2015	6	0
2016	11	0
2017	5	0
2018	7	0
2019	9	0
2020	9	0
2021	10	0
2022	16	0
2023	13	0
2024	13	0
2025	13	0
2026	6	0

FIG. 1 — Lineage of K961591, 1992–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 K253184 Video Rhinolaryngoscope System (Disposable…score 14.4 · 12 generations · no Class I recall
#2 Held for the reportin the report
#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.

Type	Number	Device	Applicant	Decided	Recalls
*	K921244	Disposable Protective Sheath Summary page 1 …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	—
*	K925421	Endosheath Summary page 1 …). 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	—
*	K933247	Protective Sheath for Flexible Nasophary/Larygnos Summary page 1 …cate 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.

Number	Device	Applicant	Decided	Descendants
K990354	Endosheath	Vision-Sciences, Inc.	1999	180
K963795	Vision-Sciences Model B-F100 Bronchoscope with Model BS-F21 Disposable Endosheath	Vision-Sciences, Inc.	1996	158
K963344	Disposable SS-F32 Endosheath for Use with the S-F100 Flexible Fiberoptic Sigmoidoscope	Vision-Sciences, Inc.	1996	2
K964100	Vision-Sciences Model SS-U32 Endo Sheath for Use with the Vsi S-F100 Flexible Fiberoptic…	Vision-Sciences, Inc.	1996	0

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

2007high 8 (2019) · low 0 (2013)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · EOB

192in 2025

2007high 282 (2014) · low 37 (2007)2026

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

Recalls per year · EOB

1in 2023

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

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

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	4	37	0	1
2008	4	38	0	1
2009	1	—	0	3
2010	1	—	0	0
2011	4	209	2	3
2012	1	—	0	4
2013	0	—	0	5
2014	3	282	0	5
2015	3	115	0	13
2016	3	174	0	16
2017	6	216	0	18
2018	6	230	0	23
2019	8	149	0	51
2020	3	175	0	47
2021	2	—	0	345
2022	6	178	1	1,158
2023	3	107	1	1,352
2024	2	—	0	1,498
2025	3	192	0	1,338
2026	5	180	1	—

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.

https://510kreport.com/device/K961591 · printed Nov 6, 2026

Cite this page

510(k) Report. “K961591: Disposable Endosheath for E-F100 Flexible Nasopharyngoscope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K961591

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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