Cleared Traditional

K032949 - SPOT CHECK PULSE OXIMETER

K032949 is an FDA 510(k) clearance for SPOT CHECK PULSE OXIMETER, manufactured by Respironics Novametrix, Inc.. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Traditional 510(k) pathway after a 336-day FDA review.

K032949 · Respironics Novametrix, Inc. · Anesthesiology device
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Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K032949

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.

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 478
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