510(k) · Cleared

Cleared

Karl Storz Direct Coupled Interface (Dci 5) Camera System

K990154510(k) TraditionalCleared Jun 1, 1999133-day reviewClass I21 CFR 878.4160

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. · FWF Camera, Television, Endoscopic, Without Audio

Cleared on Jun 1, 1999 as substantially equivalent to K973252 (Karl Storz Imaging, Inc., 1997) and 2 other predicates after a 133-day review. Its family tree reaches back 2 generations to 1988.

Decided: Jun 1, 1999
Review: 133 days
Class: Class I
Product code: FWF
Recalls: None
Predicates: 3

Its longest line of descent runs back 2 generations to K883943 (1988). 5 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK883943 CCM-1 Video Camera SystemMedical Concepts, Inc. · 1988
1 generation backK973252 Karl Storz Direct Coupled Camera HeadKarl Storz Imaging, Inc. · 1997
This deviceK990154 Karl Storz Direct Coupled Interface (Dci 5) Camera SystemKarl Storz Imaging, Inc. · 1999

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K883943	CCM-1 Video Camera System	Medical Concepts, Inc.	1988	—
−1	K973252	Karl Storz Direct Coupled Camera Head	Karl Storz Imaging, Inc.	1997	—
0 (this device)	K990154	Karl Storz Direct Coupled Interface (Dci 5) Camera System	Karl Storz Imaging, Inc.	1999	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1994	1	0
1995	2	0

FIG. 1 — Lineage of K990154, 1988–1999Source: 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 FWF? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

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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.

Type	Number	Device	Applicant	Decided	Recalls
*	K973252	Karl Storz Direct Coupled Camera Head Summary page 2 …ination of features found in earlier KSI premarket notifications. The proposed camera head and its indications for use are based upon KSI's Direct Coupled Camera 510(k), K973252. Both devices feature direct connection to an endoscope, light guide camera connection, programmable buttons, camera head focus c…	Karl Storz Imaging, Inc.	1997	—
*	K950974	Karl Storz Endovision Digivideo (Digital Image Processor) Accessory for Color Television… Summary page 2 …c image rotation, sealed aluminum camera housings, single CCD sensing and anti-fogging features. The proposed camera IPM CCU board is based upon KSI's Digivideo 510(k), K950974. Both units feature contrast enhancement, use of standard video signal, and digital processing. The proposed camera system’s CCU…	Karl Storz Imaging, Inc.	1995	—
*	K940283	Karl Storz Endovision Urocam/Hysterocam Summary page 2 …units feature contrast enhancement, use of standard video signal, and digital processing. The proposed camera system’s CCU is based upon KSI's Urocam/Hysterocam 510(k), K940283. Both units feature the same power supply, maximum signal amplification, electronic shutter control, composite video output and c…	Medical Concepts, Inc.	1994	—

What descends from it?

No later submission names this one as a predicate yet.

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 11 years and passes through 2 companies; a new generation was cleared every 9.2 years on median.
None of the 5 ancestors has a recall.

How does its category compare?

All FWF devices

FWF Camera, Television, Endoscopic, Without Audio: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FWF

FDA has decided no FWF device since 2007.

Median 510(k) review, days · FWF

Too few FWF 510(k)s in any year since 2007 to give a median.

Recalls per year · FWF

2in 2007

2007high 2 (2007) · low 0 (2008)2026

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

Adverse event reports per year · FWF

27in 2025

2007high 40 (2019) · low 0 (2014)2025

MAUDE reports naming product code FWF, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	—	2	1
2008	—	0	6
2009	—	0	1
2010	—	0	5
2011	—	0	2
2012	—	0	1
2013	—	0	6
2014	—	0	0
2015	—	0	0
2016	—	0	0
2017	—	0	4
2018	—	0	9
2019	—	0	40
2020	—	0	23
2021	—	0	28
2022	—	0	40
2023	—	0	25
2024	—	0	20
2025	—	0	27
2026	—	0	—

What is it indicated for?

The Karl Storz Imaging (KSI) Direct Coupled Interface (DCI 5) Camera System is a color, television camera head with integrated light source cable, and separate video processor.

The camera system is suitable for use with any KST DCI rigid or flexible endoscope, including, but not limited to sinoscopes, colonoscopes, sigmoidoscopes, bronchoscopes, gastroscopes, laparoscopes, choledochoscopes, ureteroscopes, hysteroscopes and arthroscopes. The camera head is coupled to the endoscope by directly pressing the endoscope onto the front of the DCI 5 camera head until it locks into place. The endoscopic image can be displayed on any standard operating room video monitor.

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/K990154 · printed Nov 6, 2026

Cite this page

510(k) Report. “K990154: Karl Storz Direct Coupled Interface (Dci 5) Camera System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K990154

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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