Cleared Traditional

K942347 - NELLCOR SYMPHONY PULSE OXIMETER MODEL N...

K942347 is the FDA 510(k) clearance for NELLCOR SYMPHONY PULSE OXIMETER MODEL N... by Nellcor, Inc.. It is a Class 2 Anesthesiology device (product code DQA) cleared through the Traditional 510(k) pathway after a 360-day FDA review.

K942347 · Nellcor, Inc. · Anesthesiology device
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May 1995
Decision
360d
Days
Class 2
Risk

K942347 is an FDA 510(k) clearance for the NELLCOR SYMPHONY PULSE OXIMETER MODEL N-3000. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Nellcor, Inc. (Lenexa, US). The FDA issued a Cleared decision on May 12, 1995 after a review of 360 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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

Submission Details

510(k) Number K942347 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 17, 1994
Decision Date May 12, 1995
Days to Decision 360 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
220d slower than avg
Panel avg: 140d · This submission: 360d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 249
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K942347.
VITAL STATISTICS SYSTEM (O-CATH ACCESSORY)
K964978 · Quinton, Inc. · May 1997
SC9000/SC9015 MEDICAL INFORMATION BUS (MIS) PROTOCOL CONVERTER
K970368 · Siemens Medical Solutions USA, Inc. · May 1997
OHMEDA 3800 PULSE OXIMETER
K962127 · Ohmeda Medical · Oct 1996
MARQUETTE ADULT/NEONATAL WRAP SENSOR
K943817 · Marquette Electronics, Inc. · Oct 1994
HP M1722A/B AND M1723A/B CODEMASTER
K944608 · Hewlett-Packard Co. · Oct 1994
OHMEDA HAND HELD OXIMETER
K931304 · Ohmeda Medical · Sep 1994