Cleared Traditional

K904039 - REFLECTANCE SENSOR (RS-10)

K904039 is an FDA 510(k) clearance for REFLECTANCE SENSOR (RS-10), manufactured by Nellcor, Inc.. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Traditional 510(k) pathway after a 114-day FDA review.

K904039 · Nellcor, Inc. · Anesthesiology device
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Dec 1990
Decision
114d
Days
Class 2
Risk

K904039 is an FDA 510(k) clearance for the REFLECTANCE SENSOR (RS-10). Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Nellcor, Inc. (Hayward, US). The FDA issued a Cleared decision on December 27, 1990 after a review of 114 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 870.2700 - the FDA anesthesiology and respiratory 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 Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Nellcor, Inc. devices

FDA 510(k) Submission Details - K904039

510(k) Number K904039 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 1990
Decision Date December 27, 1990
Days to Decision 114 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
26d faster than avg
Panel avg: 140d · This submission: 114d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQA Device Classification - Class 2, Special Controls

Product Code DQA Oximeter
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 Anesthesiology devices follow this clearance model.

Regulatory Peers - DQA Oximeter

All 502
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K904039.
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K900001 · Ge Medical Systems Information Technologies · Nov 1990
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K903523 · Hewlett-Packard Co. · Oct 1990
MODEL 90421 FLEXPORT INTERFACE
K903702 · Spacelabs, Inc. · Oct 1990