Cleared Traditional

K131226 - NOVAPROBE LED LIGHT SOURCE

K131226 is an FDA 510(k) clearance for NOVAPROBE LED LIGHT SOURCE, manufactured by Novaprobe Incorporated. The device is a Class 2 Gastroenterology & Urology device with product code FCW cleared through the Traditional 510(k) pathway after a 450-day FDA review.

K131226 · Novaprobe Incorporated · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2014
Decision
450d
Days
Class 2
Risk

K131226 is an FDA 510(k) clearance for the NOVAPROBE LED LIGHT SOURCE. Classified as Light Source, Fiberoptic, Routine (product code FCW), Class II - Special Controls.

Submitted by Novaprobe Incorporated (Lansdale, US). The FDA issued a Cleared decision on July 24, 2014 after a review of 450 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Gastroenterology & Urology submissions.

View all Novaprobe Incorporated devices

FDA 510(k) Submission Details - K131226

510(k) Number K131226 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 2013
Decision Date July 24, 2014
Days to Decision 450 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
320d slower than avg
Panel avg: 130d · This submission: 450d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FCW Device Classification - Class 2, Special Controls

Product Code FCW Light Source, Fiberoptic, Routine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - FCW Light Source, Fiberoptic, Routine

All 13
Devices cleared under the same product code (FCW) and FDA review panel - the closest regulatory comparables to K131226.
POWER LED 175
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ENDOLIGHT LED 1.1 ENDOLIGHTLED 1.2
K121724 · Richard Wolf Medical Instruments Corp. · Sep 2012
KARL STORZ LED NOVA 100 COLD LIGHT FOUNTAIN, MODELS 2016020, 20161020C
K091968 · KARL STORZ Endoscopy-America, Inc. · Sep 2009
STRYKER LED LIGHTSOURCE
K082813 · Stryker Corp. · Dec 2008
ENDOSPOT
K963043 · Corin USA · Sep 1996
WELCH ALLYN HI - LUX ILLUMINATOR
K951647 · Welch Allyn, Inc. · May 1995