510(k) · Cleared

Cleared

Vision System Colonscope

K943895510(k) TraditionalCleared Feb 3, 1995178-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

Vision-Sciences, Inc. · FDF Colonoscope And Accessories, Flexible/Rigid

Cleared on Feb 3, 1995 after a 178-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 43 later devices descend from it.

Decided: Feb 3, 1995
Review: 178 days
Class: Class II
Product code: FDF
Recalls: None
Predicates: 0

43 later devices descend from it, 3 citing it directly.

This deviceK943895 Vision System ColonscopeVision-Sciences, Inc. · 1995
Descendant · cites it directly · 38 of its ownK032688 Colonosight Model 510BSightline Technologies, Ltd. · 2004
Descendant · 2 generations on · 13 of its ownK091305 ClearpathEasyglide, Ltd. · 2009
Descendant · 2 generations on · 13 of its ownK052930 Navigator Endoscopy SystemNeoguide Systems, Inc. · 2006
Descendant · 2 generations on · 12 of its ownK070622 Neoguide Endoscopy SystemNeoguide Systems, Inc. · 2007
Descendant · 3 generations on · 10 of its ownK093779 Clearpath UgiEasyglide, Ltd. · 2010

Showing 5 of 43 descendants. See all descendants

Descendants cleared per year

1996high 6 (2012) · low 0 (1997)2026

Most influential descendants

Showing 5 of 43 · See all

K032688Colonosight Model 510BSightline Technologies, Ltd. · 2004 · cites it directly38descendants
K091305ClearpathEasyglide, Ltd. · 2009 · 2 generations on13descendants
K052930Navigator Endoscopy SystemNeoguide Systems, Inc. · 2006 · 2 generations on13descendants
K070622Neoguide Endoscopy SystemNeoguide Systems, Inc. · 2007 · 2 generations on12descendants
K093779Clearpath UgiEasyglide, Ltd. · 2010 · 3 generations on10descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K943895	Vision System Colonscope	Vision-Sciences, Inc.	1995	—
+1	K032688	Colonosight Model 510B	Sightline Technologies, Ltd.	2004	—
+2	K091305	Clearpath	Easyglide, Ltd.	2009	—
+2	K052930	Navigator Endoscopy System	Neoguide Systems, Inc.	2006	—
+2	K070622	Neoguide Endoscopy System	Neoguide Systems, Inc.	2007	—
+3	K093779	Clearpath Ugi	Easyglide, Ltd.	2010	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1996	2	0
2004	1	0
2006	3	0
2007	1	0
2008	1	0
2009	1	0
2010	3	0
2012	6	0
2013	2	0
2014	3	0
2015	2	0
2016	4	0
2017	4	0
2018	2	0
2019	2	0
2020	1	0
2021	1	0
2022	1	0
2023	1	0
2024	1	0
2026	1	0

FIG. 1 — Lineage of K943895, 1995–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in FDF? 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 FDF device

#1 K230332 Ambu® aScope™ Colon; Ambu® aBox™ 2score 20.1 · 8 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?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (43)

See all 43

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

Number	Device	Applicant	Decided	Descendants
K032688	Colonosight Model 510B	Sightline Technologies, Ltd.	2004	38
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?

Of its descendants, K032688 (Sightline Technologies, Ltd., 2004) has gone furthest, with 38 descendants of its own.

How does its category compare?

All FDF devices

FDF Colonoscope And Accessories, Flexible/Rigid: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FDF

4in 2025

2007high 7 (2012) · low 2 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FDF

194in 2025

2007high 250 (2020) · low 30 (2021)2026

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

Recalls per year · FDF

8in 2023

2007high 8 (2023) · low 0 (2007)2026

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

Adverse event reports per year · FDF

17,231in 2025

2007high 17,231 (2025) · low 48 (2010)2025

MAUDE reports naming product code FDF, 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	70	0	81
2008	2	—	0	68
2009	6	91	0	83
2010	4	101	0	48
2011	2	—	0	77
2012	7	241	0	88
2013	2	—	0	63
2014	6	164	0	60
2015	2	—	1	100
2016	7	98	1	170
2017	4	36	0	370
2018	7	101	0	388
2019	4	56	0	417
2020	4	250	1	687
2021	3	30	0	2,444
2022	5	147	0	8,345
2023	6	203	8	11,748
2024	2	—	0	12,128
2025	4	194	0	17,231
2026	5	147	0	—

https://510kreport.com/device/K943895 · printed Nov 6, 2026

Cite this page

510(k) Report. “K943895: Vision System Colonscope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K943895

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026