Cleared Traditional

K963903 - BIOSPECTROMETER-NB OXIMETER IIII

K963903 is an FDA 510(k) clearance for BIOSPECTROMETER-NB OXIMETER IIII, manufactured by Hutchinson Technology, Inc.. The device is a Class 2 Cardiovascular device with product code MUD cleared through the Traditional 510(k) pathway after a 484-day FDA review.

K963903 · Hutchinson Technology, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1998
Decision
484d
Days
Class 2
Risk

K963903 is an FDA 510(k) clearance for the BIOSPECTROMETER-NB OXIMETER IIII. Classified as Oximeter, Tissue Saturation (product code MUD), Class II - Special Controls.

Submitted by Hutchinson Technology, Inc. (Hutchinson, US). The FDA issued a Cleared decision on January 27, 1998 after a review of 484 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2700 - the FDA cardiovascular device oversight 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 Cardiovascular submissions.

View all Hutchinson Technology, Inc. devices

FDA 510(k) Submission Details - K963903

510(k) Number K963903 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 1996
Decision Date January 27, 1998
Days to Decision 484 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
359d slower than avg
Panel avg: 125d · This submission: 484d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MUD Device Classification - Class 2, Special Controls

Product Code MUD Oximeter, Tissue Saturation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2700
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 Cardiovascular devices follow this clearance model.