510(k) · Cleared

Cleared

Flexiscope, Models 50MH and 50 MHC

K053412510(k) TraditionalCleared Feb 23, 200678-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

Schoelly Imaging, Inc. · FWF Camera, Television, Endoscopic, Without Audio

Cleared on Feb 23, 2006 as substantially equivalent to K933868 (Angiolaz, Inc., 1993) after a 78-day review. Its family tree reaches back 1 generation to 1993. 1 later device descends from it.

Decided: Feb 23, 2006
Review: 78 days
Class: Class I
Product code: FWF
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K933868 (1993). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK933868 Angiolaz Video Endoscopic System Model CAMLUM1 and AccessoriesAngiolaz, Inc. · 1993
This deviceK053412 Flexiscope, Models 50MH and 50 MHCSchoelly Imaging, Inc. · 2006
Descendant · cites it directly · 0 of its ownK090601 FSC 2Schoelly Imaging, Inc. · 2009

Most influential descendants

Showing 1 of 1 · See all

K090601FSC 2Schoelly Imaging, Inc. · 2009 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K933868	Angiolaz Video Endoscopic System Model CAMLUM1 and Accessories	Angiolaz, Inc.	1993	—
0 (this device)	K053412	Flexiscope, Models 50MH and 50 MHC	Schoelly Imaging, Inc.	2006	—
+1	K090601	FSC 2	Schoelly Imaging, Inc.	2009	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2009	1	0

FIG. 1 — Lineage of K053412, 1993–2009Source: 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? (2)

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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

Type	Number	Device	Applicant	Decided	Recalls
*	K933868	Angiolaz Video Endoscopic System Model CAMLUM1 and Accessories Summary page 1 …Xenon Arc / GCT Camera, Television, Endoscopic, without Audio / FWF (510(k)-exempt) Predicate Devices AngioLaz Video Endoscopic System (K933868) AMD Telemedicine AMD-300s Illumination & Imaging System (K9402i;'y Indications for Use: The FlexiScope…	Angiolaz, Inc.	1993	—
Kept off the family tree	K940217	AMD Telemedicine AMD-300s Illumination & Imaging System Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

What descends from it? (1)

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

Number	Device	Applicant	Decided	Descendants
K090601	FSC 2	Schoelly Imaging, Inc.	2009	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, K090601 (Schoelly Imaging, Inc., 2009) has gone furthest, with 0 descendants of its own.

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 FlexiScope 5OMH / 5OMHC is indicated for use in conjunction with endoscopic devices to provide illumination and video visualization of optical images.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K053412 · printed Nov 6, 2026

Cite this page

510(k) Report. “K053412: Flexiscope, Models 50MH and 50 MHC.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053412

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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