510(k) · Cleared

Cleared

Endosheath

K990354510(k) SpecialCleared Mar 31, 199954-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 Mar 31, 1999 as substantially equivalent to K950809 (Vision-Sciences, Inc., 1996) and 4 other predicates after a 54-day review. Its family tree reaches back 2 generations to 1992. 180 later devices descend from it.

Decided: Mar 31, 1999
Review: 54 days
Class: Class II
Product code: EOB
Recalls: None
Predicates: 5

Its longest line of descent runs back 2 generations to K921244 (1992). 5 ancestors in all. 180 later devices descend from it, 12 citing it directly.

By dateBy generation

Root · 2 generations backK921244 Disposable Protective SheathVision-Sciences, Inc. · 1992
1 generation backK961591 Disposable Endosheath for E-F100 Flexible NasopharyngoscopeVision-Sciences, Inc. · 1996
This deviceK990354 EndosheathVision-Sciences, Inc. · 1999
Descendant · cites it directly · 157 of its ownK012543 Vision Sciences Endosheath SystemVision-Sciences, Inc. · 2002
Descendant · cites it directly · 157 of its ownK021344 B-F200 Bronchoscope with BSS-F21 Endosheath SystemVision-Sciences, Inc. · 2002
Descendant · cites it directly · 92 of its ownK031786 Tne-2000 Esophagoscope with Ecs-D Endosheath SystemVision-Sciences, Inc. · 2003
Descendant · 2 generations on · 70 of its ownK072088 Flexible Trans-Nasal Video Esophagoscope with Digital Video…Vision-Sciences, Inc. · 2007
Descendant · 2 generations on · 66 of its ownK091768 Video Sciences BRS-5000 Video Bronchoscope with Endosheath System…Vision-Sciences, Inc. · 2009

Showing 5 of 180 descendants. See all descendants

Descendants cleared per year

2002high 16 (2022) · low 2 (2002)2026

Most influential descendants

Showing 5 of 180 · See all

K012543Vision Sciences Endosheath SystemVision-Sciences, Inc. · 2002 · cites it directly157descendants
K021344B-F200 Bronchoscope with BSS-F21 Endosheath SystemVision-Sciences, Inc. · 2002 · cites it directly157descendants
K031786Tne-2000 Esophagoscope with Ecs-D Endosheath SystemVision-Sciences, Inc. · 2003 · cites it directly92descendants
K072088Flexible Trans-Nasal Video Esophagoscope with Digital Video Processor and Disposable…Vision-Sciences, Inc. · 2007 · 2 generations on70descendants
K091768Video Sciences BRS-5000 Video Bronchoscope with Endosheath System, Dpu-5000/Dpu-5050…Vision-Sciences, Inc. · 2009 · 2 generations on66descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K921244	Disposable Protective Sheath	Vision-Sciences, Inc.	1992	—
−1	K961591	Disposable Endosheath for E-F100 Flexible Nasopharyngoscope	Vision-Sciences, Inc.	1996	—
0 (this device)	K990354	Endosheath	Vision-Sciences, Inc.	1999	—
+1	K012543	Vision Sciences Endosheath System	Vision-Sciences, Inc.	2002	—
+1	K021344	B-F200 Bronchoscope with BSS-F21 Endosheath System	Vision-Sciences, Inc.	2002	—
+1	K031786	Tne-2000 Esophagoscope with Ecs-D Endosheath System	Vision-Sciences, Inc.	2003	—
+2	K072088	Flexible Trans-Nasal Video Esophagoscope with Digital Video Processor and…	Vision-Sciences, Inc.	2007	—
+2	K091768	Video Sciences BRS-5000 Video Bronchoscope with Endosheath System…	Vision-Sciences, Inc.	2009	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1993	2	0
1996	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
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 K990354, 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? (5)

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
*	K950809	Vision-Sciences Disposable Endosheath for Flexible Nasopharyngo-Laryngoscopes Summary page 1 …ve sheath for endoscope Classification: According to Section 513 of the Federal Food, Drug, and Cosmetic Act, the device classification is Class II. Predicate Devices: K950809 - Modified ENT EndoSheaths® K961591 - EndoSheath® for E-F100 ENT Scope K933247 - ENT EndoSheath® K925421 - ENT EndoSheath® K92124…	Vision-Sciences, Inc.	1996	—
*	K961591	Disposable Endosheath for E-F100 Flexible Nasopharyngoscope Summary page 1 …ion: According to Section 513 of the Federal Food, Drug, and Cosmetic Act, the device classification is Class II. Predicate Devices: K950809 - Modified ENT EndoSheaths® K961591 - EndoSheath® for E-F100 ENT Scope K933247 - ENT EndoSheath® K925421 - ENT EndoSheath® K921244 - ENT EndoSheath® Manufactured by…	Vision-Sciences, Inc.	1996	—
*	K933247	Protective Sheath for Flexible Nasophary/Larygnos Summary page 1 …l Food, Drug, and Cosmetic Act, the device classification is Class II. Predicate Devices: K950809 - Modified ENT EndoSheaths® K961591 - EndoSheath® for E-F100 ENT Scope K933247 - ENT EndoSheath® K925421 - ENT EndoSheath® K921244 - ENT EndoSheath® Manufactured by: Vision-Sciences, Inc. 9 Strathmore Road N…	Vision-Sciences, Inc.	1993	—
*	K925421	Endosheath Summary page 1 …Act, the device classification is Class II. Predicate Devices: K950809 - Modified ENT EndoSheaths® K961591 - EndoSheath® for E-F100 ENT Scope K933247 - ENT EndoSheath® K925421 - ENT EndoSheath® K921244 - ENT EndoSheath® Manufactured by: Vision-Sciences, Inc. 9 Strathmore Road Natick, MA 01760 Product D…	Vision-Sciences, Inc.	1993	—
*	K921244	Disposable Protective Sheath Summary page 1 …ation is Class II. Predicate Devices: K950809 - Modified ENT EndoSheaths® K961591 - EndoSheath® for E-F100 ENT Scope K933247 - ENT EndoSheath® K925421 - ENT EndoSheath® K921244 - ENT EndoSheath® Manufactured by: Vision-Sciences, Inc. 9 Strathmore Road Natick, MA 01760 Product Description: The devices de…	Vision-Sciences, Inc.	1992	—

Also cleared against K950809: 3 other devices →

What descends from it? (180)

See all 180

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

Number	Device	Applicant	Decided	Descendants
K012543	Vision Sciences Endosheath System	Vision-Sciences, Inc.	2002	157
K021344	B-F200 Bronchoscope with BSS-F21 Endosheath System	Vision-Sciences, Inc.	2002	157
K031786	Tne-2000 Esophagoscope with Ecs-D Endosheath System	Vision-Sciences, Inc.	2003	92
K032688	Colonosight Model 510B	Sightline Technologies, Ltd.	2004	38
K024095	Modification to Vision Sciences Endosheath System	Vision-Sciences, Inc.	2003	31
K050972	Vision-Sciences Ent-3000 Scope	Vision-Sciences, Inc.	2005	30
K040984	Vision Sciences Model Ent-2000V Flexible Nasopharyngo-Laryngoscope	Vision-Sciences, Inc.	2004	30
K041077	Imalux Oct Probe Guide	Imalux Corporation	2004	10
K101734	Visionscope High Definition Endoscopy Camera System with; Camera Control Unit; Camera…	Visionscope Technologies, LLC	2010	7
K061663	Endomedical Technologies Quik-Cover Flexible Endoscope Barrier Sheath for…	Rtc Inc.-Memcath Technologies, LLC	2006	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?

The line of descent spans 7 years and passes through 1 company; a new generation was cleared every 3.7 years on median.
None of the 5 ancestors has a recall.
Of its descendants, K012543 (Vision-Sciences, Inc., 2002) has gone furthest, with 157 descendants of its own.
3 other devices also cite its predicate K950809.

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 flexible 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/K990354 · printed Nov 6, 2026

Cite this page

510(k) Report. “K990354: Endosheath.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K990354

Report an extraction error

Are you the manufacturer?

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