510(k) Report

510(k) · Cleared

Cleared

FSC 2

K090601510(k) TraditionalCleared May 11, 200967-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

Schoelly Imaging, Inc. · NTN Led Light Source

Cleared on May 11, 2009 as substantially equivalent to K053412 (Schoelly Imaging, Inc., 2006) after a 67-day review. Its family tree reaches back 2 generations to 1993.

Decided
May 11, 2009
Review
67 days
Class
Class II
Product code
NTN
Recalls
None
Predicates
1

Its longest line of descent runs back 2 generations to K933868 (1993). No later device cites it as a predicate yet.

K933868 · Angiolaz Video Endoscopic System Model CAMLUM1 and Accessories · Angiolaz, Inc. · 1993K053412 · Flexiscope, Models 50MH and 50 MHC · Schoelly Imaging, Inc. · 200619901995200020052010
K053412 · Flexiscope, Models 50MH and 50 MHC · Schoelly Imaging, Inc. · 2006K933868 · Angiolaz Video Endoscopic System Model CAMLUM1 and Accessories · Angiolaz, Inc. · 19930
  1. Root · 2 generations backK933868 Angiolaz Video Endoscopic System Model CAMLUM1 and AccessoriesAngiolaz, Inc. · 1993
  2. 1 generation backK053412 Flexiscope, Models 50MH and 50 MHCSchoelly Imaging, Inc. · 2006
  3. This deviceK090601 FSC 2Schoelly Imaging, Inc. · 2009
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K933868Angiolaz Video Endoscopic System Model CAMLUM1 and AccessoriesAngiolaz, Inc.1993—
−1K053412Flexiscope, Models 50MH and 50 MHCSchoelly Imaging, Inc.2006—
0 (this device)K090601FSC 2Schoelly Imaging, Inc.2009—
FIG. 1 — Lineage of K090601, 1993–2009Source: 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), 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 NTN? 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K053412Flexiscope, Models 50MH and 50 MHC
Summary page 1
…Common Name: Surgical camera and accessories Device Class: 21 CFR 878.4160, Class I, exempt Product Code FWF C) Predicates: Schoelly FSC 5OMH K053412 21 CFR 876.1500, Endoscope and accessories, Class II, Product code GCT and FWC 21 CFR 878-4160, Surgical camera and…
Schoelly Imaging, Inc.2006—

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 16 years and passes through 2 companies; a new generation was cleared every 12.3 years on median.
  • None of the 2 ancestors has a recall.

How does its category compare?

All NTN devices

NTN Led Light Source: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · NTN

1in 2015

2009: 22010: 12011: 12012: 22013: 12014: 12015: 1
2007high 2 (2009) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NTN

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

Recalls per year · NTN

No recall names NTN since 2007.

Adverse event reports per year · NTN

42in 2025

2013: 12016: 12017: 22019: 12020: 562021: 472022: 472023: 262024: 322025: 42
2007high 56 (2020) · low 0 (2007)2025

MAUDE reports naming product code NTN, 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
20070—00
20080—00
20092—00
20101—00
20111—00
20122—00
20131—01
20141—00
20151—00
20160—01
20170—02
20180—00
20190—01
20200—056
20210—047
20220—047
20230—026
20240—032
20250—042
20260—0—

What is it indicated for?

The FSC 2 is intended to be used in conjunction with endoscopic devices to provide illumination and video visualization of optical images to visualize and observe body spaces.

Indications for use as stated in the FDA summary.

More from Schoelly Imaging, Inc.

5 FDA decisions under this applicant name. See the company

  • K090800VS-100 Illumination and Imaging SystemSchoelly Imaging, Inc. · 2009
  • K083553Naso-Laryngo-PharyngoscopeSchoelly Imaging, Inc. · 2009
  • K060899Flexilux II Cystoscope and HysteroscopeSchoelly Imaging, Inc. · 2007
  • K053412Flexiscope, Models 50MH and 50 MHCSchoelly Imaging, Inc. · 2006

Recent decisions in NTN

The NTN category page

  • K141164Artemis Light EngineQuest Medical Imaging · 2015
  • K133311EndoledOlympus Winter & Ibe GmbH · 2014
  • K130819CLL- V1 Light SourceOlympus Winter & Ibe GmbH · 2013
  • K122831Video System CenterOlympus Medical Systems Corp. · 2012
  • K113679Lucea Led Surgical Light SystemMaquet S.A.S. · 20121 recall

https://510kreport.com/device/K090601 · printed Nov 4, 2026

Cite this page

510(k) Report. “K090601: FSC 2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K090601

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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