510(k) · Cleared

Cleared

HD Camera Head Otv-S7PROH-HD-L08E

K083155510(k) TraditionalCleared Jan 13, 200981-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

Olympus Medical Systems Corporation · FET Endoscopic Video Imaging System/Component, Gastroenterology-Urology

Cleared on Jan 13, 2009 as substantially equivalent to K955404 (Olympus America, Inc., 1996) after an 81-day review. Its family tree reaches back 1 generation to 1996. 11 later devices descend from it.

Decided: Jan 13, 2009
Review: 81 days
Class: Class II
Product code: FET
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K955404 (1996). 11 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK955404 Otv-S5 Oes Video SystemOlympus America, Inc. · 1996
This deviceK083155 HD Camera Head Otv-S7PROH-HD-L08EOlympus Medical Systems Corporation · 2009
Descendant · cites it directly · 10 of its ownK102059 Autoclavable Camer Head Model Otv-Y0017Olympus Medical Systems Corporation · 2010
Descendant · 2 generations on · 5 of its ownK190449 Visera Elite II Video System Center, Visera Elite II HD 3CMOS…Olympus Medical Systems Corp. · 2019
Descendant · 2 generations on · 3 of its ownK151011 Visera 4K Uhd SystemOlympus Medical Systems Corp. · 2015
Descendant · 3 generations on · 2 of its ownK242067 Visera Elite Iii Video System Center Olympus Otv-S700; Visera Elite…Olympus Corporations of the Americas · 2025
Descendant · 4 generations on · 0 of its ownK262079 4K Camera Head OLYMPUS CH-S700-08-LBOlympus Medical Systems Corp. · 2026

Showing 5 of 11 descendants. See all descendants

Descendants cleared per year

2010high 3 (2025) · low 0 (2011)2026

Most influential descendants

Showing 5 of 11 · See all

K102059Autoclavable Camer Head Model Otv-Y0017Olympus Medical Systems Corporation · 2010 · cites it directly10descendants
K190449Visera Elite II Video System Center, Visera Elite II HD 3CMOS Autoclavable Camera Head…Olympus Medical Systems Corp. · 2019 · 2 generations on5descendants
K151011Visera 4K Uhd SystemOlympus Medical Systems Corp. · 2015 · 2 generations on3descendants
K242067Visera Elite Iii Video System Center Olympus Otv-S700; Visera Elite Iii Led Light Source…Olympus Corporations of the Americas · 2025 · 3 generations on2descendants
K2620794K Camera Head OLYMPUS CH-S700-08-LBOlympus Medical Systems Corp. · 2026 · 4 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K955404	Otv-S5 Oes Video System	Olympus America, Inc.	1996	—
0 (this device)	K083155	HD Camera Head Otv-S7PROH-HD-L08E	Olympus Medical Systems Corporation	2009	—
+1	K102059	Autoclavable Camer Head Model Otv-Y0017	Olympus Medical Systems Corporation	2010	—
+2	K190449	Visera Elite II Video System Center, Visera Elite II HD 3CMOS Autoclavable…	Olympus Medical Systems Corp.	2019	—
+2	K151011	Visera 4K Uhd System	Olympus Medical Systems Corp.	2015	—
+3	K242067	Visera Elite Iii Video System Center Olympus Otv-S700; Visera Elite Iii Led…	Olympus Corporations of the Americas	2025	—
+4	K262079	4K Camera Head OLYMPUS CH-S700-08-LB	Olympus Medical Systems Corp.	2026	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2010	1	0
2015	1	0
2017	1	0
2019	1	0
2020	2	0
2025	3	0
2026	2	0

FIG. 1 — Lineage of K083155, 1996–2026Source: 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 FET? 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 FET device

#1 K242067 Visera Elite Iii Video System Center Olympus…score 18.4 · 12 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (1)

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
*	K955404	Otv-S5 Oes Video System Summary page 2 …n: HD CAMERA HEAD LA Camera Head for rigid endoscopes (Wi HEAD~~~~~~~~~~~ K955404 OTV-S7ProH-HD-LO8E Auto focus) MH-9721 4 Device Description HD CAMERA HEAD OTV-S7ProH-HD-LO8E i…	Olympus America, Inc.	1996	—

Also cleared against K955404: 3 other devices →

What descends from it? (11)

See all 11

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K102059	Autoclavable Camer Head Model Otv-Y0017	Olympus Medical Systems Corporation	2010	10

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?

Its one ancestor has no recall.
Of its descendants, K102059 (Olympus Medical Systems Corporation, 2010) has gone furthest, with 10 descendants of its own.
3 other devices also cite its predicate K955404.

How does its category compare?

All FET devices

FET Endoscopic Video Imaging System/Component, Gastroenterology-Urology: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · FET

6in 2025

2007high 6 (2025) · low 0 (2014)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FET

166in 2025

2007high 166 (2025) · low 25 (2019)2026

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

Recalls per year · FET

1in 2024

2007high 2 (2023) · low 0 (2007)2026

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

Adverse event reports per year · FET

14,530in 2025

2007high 14,530 (2025) · low 1 (2008)2025

MAUDE reports naming product code FET, 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	1	—	0	2
2008	2	—	0	1
2009	2	—	0	6
2010	1	—	0	3
2011	2	—	0	7
2012	2	—	0	11
2013	2	—	0	8
2014	0	—	0	3
2015	2	—	0	3
2016	1	—	0	25
2017	3	119	0	66
2018	3	98	0	67
2019	3	25	0	72
2020	5	106	0	3,043
2021	1	—	0	5,300
2022	2	—	0	6,156
2023	1	—	2	8,199
2024	2	—	1	13,153
2025	6	166	0	14,530
2026	3	69	0	—

What is it indicated for?

This camera head has been designed to be used with the CV-180 EXERA II video system center or O!V-S7Pro VISERA Pro video system center, endoscopes, light sources, video monitors and other ancillary equipment for endoscopic diagnosis and treatment within the bladder, urethra, ureter, and kidney.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K083155 · printed Nov 6, 2026

Cite this page

510(k) Report. “K083155: HD Camera Head Otv-S7PROH-HD-L08E.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083155

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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