Cleared Traditional

K890448 - LIGHT SOURCE

K890448 is an FDA 510(k) clearance for LIGHT SOURCE, manufactured by Mira, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FFS cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K890448 · Mira, Inc. · Gastroenterology & Urology device
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May 1989
Decision
101d
Days
Class 2
Risk

K890448 is an FDA 510(k) clearance for the LIGHT SOURCE, ENDOSCOP, XENON ARC. Classified as Image, Illumination, Fiberoptic, For Endoscope (product code FFS), Class II - Special Controls.

Submitted by Mira, Inc. (Waltham, US). The FDA issued a Cleared decision on May 8, 1989 after a review of 101 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Mira, Inc. devices

FDA 510(k) Submission Details - K890448

510(k) Number K890448 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 1989
Decision Date May 08, 1989
Days to Decision 101 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
29d faster than avg
Panel avg: 130d · This submission: 101d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FFS Device Classification - Class 2, Special Controls

Product Code FFS Image, Illumination, Fiberoptic, For Endoscope
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 - FFS Image, Illumination, Fiberoptic, For Endoscope

All 7
Devices cleared under the same product code (FFS) and FDA review panel - the closest regulatory comparables to K890448.
KARL STORZ XENON 300 LIGHT SOURCE FOR NON-FLASH APPLICATIONS
K962595 · KARL STORZ Endoscopy-America, Inc. · Sep 1996
KARL STORZ ENDOSCOPY-AMERICA, INC.
K933216 · KARL STORZ Endoscopy-America, Inc. · Sep 1993
FLEX SIGMOIDOSCOPE LIGHT SOURCE MODEL #45150
K893440 · Welch Allyn, Inc. · Jul 1989
FLEXIBLE LIQUID LIGHT GUIDE
K834487 · Endo Lase, Inc. · Feb 1984