510(k) · Cleared

Cleared

Cmos Video Rhino-Laryngoscope System Model 11101CM

K103467510(k) SpecialCleared Jun 28, 2012582-day reviewClass II21 CFR 874.4760

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

KARL STORZ Endoscopy-America, Inc. · EOB Nasopharyngoscope (Flexible Or Rigid)

Cleared on Jun 28, 2012 as substantially equivalent to K072387 (KARL STORZ Endoscopy-America, Inc., 2007) after a 582-day review. Its family tree reaches back 1 generation to 2007. 10 later devices descend from it.

Decided: Jun 28, 2012
Review: 582 days
Class: Class II
Product code: EOB
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K072387 (2007). 10 later devices descend from it, 6 citing it directly.

By dateBy generation

Root · 1 generation backK072387 Karl Storz Video Rhino-Laryngscope System, Model 11101 SeriesKARL STORZ Endoscopy-America, Inc. · 2007
This deviceK103467 Cmos Video Rhino-Laryngoscope System Model 11101CMKARL STORZ Endoscopy-America, Inc. · 2012
Descendant · cites it directly · 3 of its ownK132009 Cmos Video Nasopharyngoscope SystemSchoelly Fiberoptic GmbH · 2014
Descendant · cites it directly · 2 of its ownK182186 CMOS Video-Rhino-Laryngoscope SystemKARL STORZ Endoscopy-America, Inc. · 2019
Descendant · cites it directly · 1 of its ownK200609 ENTity WiFi Video Nasopharyngoscope SystemOptim, LLC · 2021
Descendant · 2 generations on · 1 of its ownK143673 CMOS Video Nasopharyngoscope SystemSchoelly Fiberoptic GmbH · 2015
Descendant · 2 generations on · 0 of its ownK254133 ENTity USB Videoscope SystemOptim, LLC · 2026

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2014high 2 (2020) · low 0 (2016)2026

Most influential descendants

Showing 5 of 10 · See all

K132009Cmos Video Nasopharyngoscope SystemSchoelly Fiberoptic GmbH · 2014 · cites it directly3descendants
K182186CMOS Video-Rhino-Laryngoscope SystemKARL STORZ Endoscopy-America, Inc. · 2019 · cites it directly2descendants
K200609ENTity WiFi Video Nasopharyngoscope SystemOptim, LLC · 2021 · cites it directly1descendant
K143673CMOS Video Nasopharyngoscope SystemSchoelly Fiberoptic GmbH · 2015 · 2 generations on1descendant
K254133ENTity USB Videoscope SystemOptim, LLC · 2026 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K072387	Karl Storz Video Rhino-Laryngscope System, Model 11101 Series	KARL STORZ Endoscopy-America, Inc.	2007	—
0 (this device)	K103467	Cmos Video Rhino-Laryngoscope System Model 11101CM	KARL STORZ Endoscopy-America, Inc.	2012	—
+1	K132009	Cmos Video Nasopharyngoscope System	Schoelly Fiberoptic GmbH	2014	—
+1	K182186	CMOS Video-Rhino-Laryngoscope System	KARL STORZ Endoscopy-America, Inc.	2019	—
+1	K200609	ENTity WiFi Video Nasopharyngoscope System	Optim, LLC	2021	—
+2	K143673	CMOS Video Nasopharyngoscope System	Schoelly Fiberoptic GmbH	2015	—
+2	K254133	ENTity USB Videoscope System	Optim, LLC	2026	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2014	1	0
2015	1	0
2018	1	0
2019	1	0
2020	2	0
2021	1	0
2023	2	0
2026	1	0

FIG. 1 — Lineage of K103467, 2007–2026Source: 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 EOB? 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 EOB device

#1 K253184 Video Rhinolaryngoscope System (Disposable…score 14.4 · 12 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? (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
*	K072387	Karl Storz Video Rhino-Laryngscope System, Model 11101 Series Summary page 1 …Name: Video Rhino-Laryngoscope System Trade Name: CMOS Video Rhino-Laryngoscope System Predicate Device: KARL STORZ VIDEO RH1NO-LARYNGSCOPE SYSTEM, MODELI 1101ISERIES (K072387) Indication: The KARL STORZ CMOS Flexible Video Rhino-Laryngoscope System may only be used by persons with an appropriate medica…	KARL STORZ Endoscopy-America, Inc.	2007	—

Also cleared against K072387: 1 other device →

What descends from it? (10)

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

Number	Device	Applicant	Decided	Descendants
K132009	Cmos Video Nasopharyngoscope System	Schoelly Fiberoptic GmbH	2014	3
K182186	CMOS Video-Rhino-Laryngoscope System	KARL STORZ Endoscopy-America, Inc.	2019	2
K200609	ENTity WiFi Video Nasopharyngoscope System	Optim, LLC	2021	1
K200740	HD Video Rhino Laryngoscope	KARL STORZ Endoscopy-America, Inc.	2020	0
K192090	CMOS Video Rhino-Laryngoscope SSU	Karl Storz SE & CO. KG	2020	0
K171011	PENTAX Medical VIVIDEO ENT Videoscope Solution	Pentax Medical	2018	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?

Its one ancestor has no recall.
Of its descendants, K132009 (Schoelly Fiberoptic GmbH, 2014) has gone furthest, with 3 descendants of its own.
1 other device also cites its predicate K072387.

How does its category compare?

All EOB devices

EOB Nasopharyngoscope (Flexible Or Rigid): FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.

FDA decisions per year · EOB

3in 2025

2007high 8 (2019) · low 0 (2013)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · EOB

192in 2025

2007high 282 (2014) · low 37 (2007)2026

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

Recalls per year · EOB

1in 2023

2007high 2 (2011) · low 0 (2007)2026

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

Adverse event reports per year · EOB

1,338in 2025

2007high 1,498 (2024) · low 0 (2010)2025

MAUDE reports naming product code EOB, 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	37	0	1
2008	4	38	0	1
2009	1	—	0	3
2010	1	—	0	0
2011	4	209	2	3
2012	1	—	0	4
2013	0	—	0	5
2014	3	282	0	5
2015	3	115	0	13
2016	3	174	0	16
2017	6	216	0	18
2018	6	230	0	23
2019	8	149	0	51
2020	3	175	0	47
2021	2	—	0	345
2022	6	178	1	1,158
2023	3	107	1	1,352
2024	2	—	0	1,498
2025	3	192	0	1,338
2026	5	180	1	—

What is it indicated for?

The KARL STORZ CMOS Flexible Video Rhino- Laryngoscope System may only be used by persons with an appropriate medical qualification and who are acquainted with the rhino/laryngoscopic technique. The endoscope is used for endoscopic diagnosis within the nasal lumens and airway anatomy, and is intended to provide visualization via a video monitor.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K103467 · printed Nov 5, 2026

Cite this page

510(k) Report. “K103467: Cmos Video Rhino-Laryngoscope System Model 11101CM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K103467

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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