510(k) Report

510(k) · Cleared

Cleared

Karl Storz Endovision Tricam, Model 20221101 (20221001, Pal Format) Color Television Camera for Endoscopic Procedures

K950862510(k) TraditionalCleared May 24, 199586-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

Karl Storz Imaging, Inc. · GCJ Laparoscope, General & Plastic Surgery

Cleared on May 24, 1995 after an 86-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 141 later devices descend from it.

Decided
May 24, 1995
Review
86 days
Class
Class II
Product code
GCJ
Recalls
None
Predicates
0

141 later devices descend from it, 6 citing it directly.

Descendants, by year cleared 2015: 3 descendants cleared1997: 1 descendant cleared2000: 1 descendant cleared1999: 3 descendants cleared1998: 1 descendant cleared2002: 2 descendants cleared2003: 2 descendants cleared2022: 13 descendants cleared2008: 2 descendants cleared2013: 3 descendants cleared2006: 1 descendant cleared2007: 1 descendant cleared2014: 3 descendants cleared2018: 5 descendants cleared2009: 1 descendant cleared2016: 5 descendants cleared2021: 10 descendants cleared2019: 4 descendants cleared2020: 10 descendants cleared2023: 14 descendants cleared2017: 4 descendants cleared2011: 1 descendant cleared2025: 18 descendants cleared2026: 20 descendants cleared2024: 13 descendants cleared1995200020052010201520202025
  1. This deviceK950862 Karl Storz Endovision Tricam, Model 20221101 (20221001, Pal Format)…Karl Storz Imaging, Inc. · 1995
  2. Descendant · cites it directly · 130 of its ownK983566 3-Chip Video CameraStryker Endoscopy · 1999 · Recalled
  3. Descendant · 2 generations on · 124 of its ownK031098 3-CCD Digital Camera SystemLinvatec Corp. · 2003
  4. Descendant · 3 generations on · 116 of its ownK063457 Truehd (1080P) Digital Camera SystemConmed Linvatec · 2006
  5. Descendant · 4 generations on · 106 of its ownK091515 Spy Scope Intra-Operative Operating SystemNovadaq Technologies, Inc. · 2009 · Recalled
  6. Descendant · 5 generations on · 104 of its ownK101077 DA Vinci Fluorescence Imaging Vision System, Model FF 100Intuitive Surgical, Inc. · 2011 · Recalled

Showing 5 of 141 descendants. See all descendants

Descendants cleared per year

1997: 11998: 11999: 32000: 12002: 22003: 22006: 12007: 12008: 22009: 12011: 12013: 32014: 32015: 32016: 52017: 42018: 52019: 42020: 102021: 102022: 132023: 142024: 132025: 182026: 20
1997high 20 (2026) · low 0 (2001)2026

Most influential descendants

Showing 5 of 141 · See all
  • K9835663-Chip Video CameraStryker Endoscopy · 1999 · cites it directly130descendants
  • K0310983-CCD Digital Camera SystemLinvatec Corp. · 2003 · 2 generations on124descendants
  • K063457Truehd (1080P) Digital Camera SystemConmed Linvatec · 2006 · 3 generations on116descendants
  • K091515Spy Scope Intra-Operative Operating SystemNovadaq Technologies, Inc. · 2009 · 4 generations on106descendants
  • K101077DA Vinci Fluorescence Imaging Vision System, Model FF 100Intuitive Surgical, Inc. · 2011 · 5 generations on104descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K950862Karl Storz Endovision Tricam, Model 20221101 (20221001, Pal Format) Color…Karl Storz Imaging, Inc.1995—
+1K9835663-Chip Video CameraStryker Endoscopy19991
+2K0310983-CCD Digital Camera SystemLinvatec Corp.2003—
+3K063457Truehd (1080P) Digital Camera SystemConmed Linvatec2006—
+4K091515Spy Scope Intra-Operative Operating SystemNovadaq Technologies, Inc.20091
+5K101077DA Vinci Fluorescence Imaging Vision System, Model FF 100Intuitive Surgical, Inc.20112

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
199810
199930
200010
200220
200320
200610
200710
200820
200910
201110
201330
201430
201530
201650
201740
201850
201940
2020100
2021100
2022130
2023140
2024130
2025180
2026200
FIG. 1 — Lineage of K950862, 1995–2026Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in GCJ? 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 GCJ device

  1. #1 K214046 780 nm 1688 4K Camera System, 780 nm L11 LED…score 21.4 · 21 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (141)

See all 141

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

NumberDeviceApplicantDecidedDescendants
K9835663-Chip Video CameraStryker Endoscopy1999130
K974391Karl Storz Endovision XL Endoscopic Camera SystemKarl Storz Imaging, Inc.19984
K143640KSEA CMOS Camera System (C-cam)KARL STORZ Endoscopy-America, Inc.20151
K014158Endoscopic Camera TC804/C4World of Medicine Lemke GmbH20021
K994090Karl Storz Autoclavable Camera HeadKarl Storz Imaging, Inc.20001
K973252Karl Storz Direct Coupled Camera HeadKarl Storz Imaging, Inc.19971

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, K983566 (Stryker Endoscopy, 1999) has gone furthest, with 130 descendants of its own.

How does its category compare?

All GCJ devices

GCJ Laparoscope, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GCJ

21in 2025

2007: 182008: 192009: 212010: 242011: 152012: 172013: 152014: 192015: 262016: 272017: 202018: 212019: 152020: 282021: 182022: 202023: 312024: 292025: 212026 (partial year): 26
2007high 31 (2023) · low 15 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GCJ

108in 2025

2007: 42 days median2008: 73 days median2009: 85 days median2010: 122 days median2011: 113 days median2012: 88 days median2013: 93 days median2014: 90 days median2015: 76 days median2016: 99 days median2017: 77 days median2018: 88 days median2019: 60 days median2020: 61 days median2021: 116 days median2022: 103 days median2023: 109 days median2024: 90 days median2025: 108 days median2026 (partial year): 122 days median
2007high 122 (2010) · low 42 (2007)2026

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

Recalls per year · GCJ

5in 2025

2007: 122008: 162009: 62010: 302011: 92012: 12013: 7, 1 Class I2014: 22016: 52017: 12018: 12022: 12023: 12025: 52026 (partial year): 1
2007high 30 (2010) · low 0 (2015)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · GCJ

5,860in 2025

2007: 1,6392008: 1,3192009: 1,9952010: 2,6572011: 2,1332012: 1,5262013: 1,5652014: 1,7142015: 1,7102016: 2,0802017: 3,4682018: 2,5622019: 2,5782020: 2,6182021: 3,4312022: 3,9452023: 6,0022024: 6,0472025: 5,860
2007high 6,047 (2024) · low 1,319 (2008)2025

MAUDE reports naming product code GCJ, 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
20071842121,639
20081973161,319
2009218561,995
201024122302,657
20111511392,133
2012178811,526
201315937 (1)1,565
2014199021,714
2015267601,710
2016279952,080
2017207713,468
2018218812,562
2019156002,578
2020286102,618
20211811603,431
20222010313,945
20233110916,002
2024299006,047
20252110855,860
2026261221—

More from Karl Storz Imaging, Inc.

10 FDA decisions under this applicant name. See the company

  • K003325Ksi's New Camera Architecture (Nca) Video Imaging SystemKarl Storz Imaging, Inc. · 2001
  • K001362Karl Storz 3D Video SystemKarl Storz Imaging, Inc. · 2000
  • K994090Karl Storz Autoclavable Camera HeadKarl Storz Imaging, Inc. · 2000
  • K990154Karl Storz Direct Coupled Interface (Dci 5) Camera SystemKarl Storz Imaging, Inc. · 1999
  • K974391Karl Storz Endovision XL Endoscopic Camera SystemKarl Storz Imaging, Inc. · 1998

Recent decisions in GCJ

The GCJ category page

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  • K260884UNIDRIVE Select SystemKarl Storz SE & CO. KG · 2026
  • K260972OEV-271MUH LCD Monitor;OEV-321MUH LCD Monitor;OEV-431MUH LCD MonitorSony Corporation · 2026
  • K261139VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103)Freyja Healthcare, LLC · 2026

https://510kreport.com/device/K950862 · printed Nov 6, 2026

Cite this page

510(k) Report. “K950862: Karl Storz Endovision Tricam, Model 20221101 (20221001, Pal Format) Color Television Camera for Endoscopic Procedures.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K950862

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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