Cleared Traditional

SPOT CHECK PULSE OXIMETER,512/513 (K032949) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K032949 · Respironics Novametrix, Inc. · Anesthesiology device
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Aug 2004
Decision
336d
Days
Class 2
Risk

K032949 is an FDA 510(k) clearance for the SPOT CHECK PULSE OXIMETER,512/513. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Respironics Novametrix, Inc. (Wallingford, US). The FDA issued a Cleared decision on August 23, 2004 after a review of 336 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 Respironics Novametrix, Inc. devices

Submission Details

510(k) Number K032949 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 2003
Decision Date August 23, 2004
Days to Decision 336 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
196d slower than avg
Panel avg: 140d · This submission: 336d
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 240
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K032949.
LNOPV AD-L AND PD-L OXIMETRY SENSORS
K050068 · Masimo Corporation · Feb 2005
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K042536 · Masimo Corporation · Jan 2005
LNCS OXIMETRY SENSORS
K042346 · Masimo Corporation · Sep 2004
THE M3810A PHILIPS TELEMONITORING SYSTEM WITH M3814A SPO2 UNIT
K041674 · Philips Medical Systems · Jul 2004
PHILIPS SPO2 REUSABLE SENSORS, MODEL NOS. M1191T, M1192T, AND M1193T
K032979 · Philips Medical Systems, Inc. · Feb 2004
PICOSAT II SP02 PULSE OXIMETRY MODULE AND M3001A MULTI-MEASUREMENT SERVER
K033715 · Philips Medical Systems, Inc. · Feb 2004