510(k) Report

510(k) · Cleared

Recalled · 2011

Endoscopic Camera TC804/C4

K014158510(k) TraditionalCleared Mar 14, 200285-day reviewClass II21 CFR 876.1500Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

World of Medicine Lemke GmbH · GCJ Laparoscope, General & Plastic Surgery

Cleared on Mar 14, 2002 as substantially equivalent to K950862 (Karl Storz Imaging, Inc., 1995) and 2 other predicates after an 85-day review. Its family tree reaches back 1 generation to 1993. 1 later device descends from it. It has been recalled once.

Decided
Mar 14, 2002
Review
85 days
Class
Class II
Product code
GCJ
Recalls
1
Predicates
3

Its longest line of descent runs back 1 generation to K914883 (1993). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1999: 1 other ancestor1995: 1 other ancestor2003: 1 descendant clearedK914883 · Circon Acmi Gen Surg Instru for Mini Invasive Surg · Circon Video · 19931990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors 1 generation forward: 1 descendant K914883 · Circon Acmi Gen Surg Instru for Mini Invasive Surg · Circon Video · 19930
  1. Root · 1 generation backK914883 Circon Acmi Gen Surg Instru for Mini Invasive SurgCircon Video · 1993
  2. This deviceK014158 Endoscopic Camera TC804/C4World of Medicine Lemke GmbH · 2002
  3. Descendant · cites it directly · 0 of its ownK032544 VP-1000; Med Cam 100; VP-3000A; Med Cam 300Mgb Endoskopische Gerate GmbH (Berlin) · 2003

Most influential descendants

Showing 1 of 1 · See all
  • K032544VP-1000; Med Cam 100; VP-3000A; Med Cam 300Mgb Endoskopische Gerate GmbH (Berlin) · 2003 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K914883Circon Acmi Gen Surg Instru for Mini Invasive SurgCircon Video1993—
0 (this device)K014158Endoscopic Camera TC804/C4World of Medicine Lemke GmbH2002—
+1K032544VP-1000; Med Cam 100; VP-3000A; Med Cam 300Mgb Endoskopische Gerate GmbH (Berlin)2003—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199510
199910

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
FIG. 1 — Lineage of K014158, 1993–2003Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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 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
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.

TypeNumberDeviceApplicantDecidedRecalls
*K950862Karl Storz Endovision Tricam, Model 20221101 (20221001, Pal Format) Color Television…
Summary page 1
…I. This device is described in 21 C.F.R. § 876.1500. The product code for the device is GCJ. IV. Predicate Devices: Karl Storz Endovision Tricam, Model 20221101 (202) (K950862) Circon MicroDigital IP 6.2 (K914883) cowy wX-s Image Technologies SteriCam, Coupler-Drape and TrowView Imaging System (K983567)…
Karl Storz Imaging, Inc.1995—
*K914883Circon Acmi Gen Surg Instru for Mini Invasive Surg
Summary page 1
….R. § 876.1500. The product code for the device is GCJ. IV. Predicate Devices: Karl Storz Endovision Tricam, Model 20221101 (202) (K950862) Circon MicroDigital IP 6.2 (K914883) cowy wX-s Image Technologies SteriCam, Coupler-Drape and TrowView Imaging System (K983567) V. Intended Use: The Endoscopic Ca…
Circon Video1993—
*K983567Image Technologies Stericam, Coupler-Drape and Troview Imaging System
Summary page 1
…Endovision Tricam, Model 20221101 (202) (K950862) Circon MicroDigital IP 6.2 (K914883) cowy wX-s Image Technologies SteriCam, Coupler-Drape and TrowView Imaging System (K983567) V. Intended Use: The Endoscopic Camera TC804/C4 is intended to attach to standard endoscopes to permit visualization of body c…
Med Images, Inc.1999—

Also cleared against K950862: 5 other devices →

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K032544VP-1000; Med Cam 100; VP-3000A; Med Cam 300Mgb Endoskopische Gerate GmbH (Berlin)20030

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Sep 23, 2011Not classifiedZ-0082-2012Process designHD1200 camera heads may cause image issues

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, K032544 (Mgb Endoskopische Gerate GmbH (Berlin), 2003) has gone furthest, with 0 descendants of its own.
  • 5 other devices also cite its predicate K950862.

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—

What is it indicated for?

The Endoscopic Camera TC804/C4 is intended to attach to standard endoscopes to permit visualization of body cavities, hollow organs and canals during endoscopic procedures. It also may be attached to a microscope. The endoscopic image can be displayed on any standard video monitor.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K950862

5 other devices cite the same predicate.

  • K143640KSEA CMOS Camera System (C-cam)KARL STORZ Endoscopy-America, Inc. · 2015
  • K994090Karl Storz Autoclavable Camera HeadKarl Storz Imaging, Inc. · 2000
  • K9835663-Chip Video CameraStryker Endoscopy · 19991 recall
  • K974391Karl Storz Endovision XL Endoscopic Camera SystemKarl Storz Imaging, Inc. · 1998
  • K973252Karl Storz Direct Coupled Camera HeadKarl Storz Imaging, Inc. · 1997

More from World of Medicine Lemke GmbH

7 FDA decisions under this applicant name. See the company

  • K024251SightfixWorld of Medicine Lemke GmbH · 2003
  • K023468Endoscopic Light Source XL180/L3World of Medicine Lemke GmbH · 2003
  • K021717Endoscopic Light Source, Model XL300/L5World of Medicine Lemke GmbH · 2002
  • K021456ER150/M2World of Medicine Lemke GmbH · 2002
  • K020889Endoscopic Light Source XL202/L3World of Medicine Lemke GmbH · 2002

Recent decisions in GCJ

The GCJ category page

  • K262455da Vinci 5 Handheld Camera Head (470080);da Vinci 5 Handheld Camera Laparoscope, 0 degree (470081);da Vinci…Intuitive Surgical, Inc. · 2026
  • K262397CuratOR EX2742Eizo Corporation · 2026
  • 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/K014158 · printed Nov 3, 2026

Cite this page

510(k) Report. “K014158: Endoscopic Camera TC804/C4.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K014158

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026