Cleared Traditional

K032755 - MODEL 509M PULSE OXIMETER

K032755 is an FDA 510(k) clearance for MODEL 509M 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 259-day FDA review.

K032755 · Respironics Novametrix, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2004
Decision
259d
Days
Class 2
Risk

K032755 is an FDA 510(k) clearance for the MODEL 509M PULSE OXIMETER, MODEL 509M. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Respironics Novametrix, Inc. (Wallingford, US). The FDA issued a Cleared decision on May 21, 2004 after a review of 259 days - an extended review cycle.

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 Respironics Novametrix, Inc. devices

FDA 510(k) Submission Details - K032755

510(k) Number K032755 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 05, 2003
Decision Date May 21, 2004
Days to Decision 259 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
119d slower than avg
Panel avg: 140d · This submission: 259d
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
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K032755.
NC SP02 ADAPTER CABLE
K041204 · Masimo Corp. · Jun 2004
AVANT DIGITAL PULSE OXIMETRY SYSTEM, MODELS 4000, 4001
K041156 · Nonin Medical, Inc. · Jun 2004
MODIFICATION TO AVANT 9600 PULSE OXIMETER
K040589 · Nonin Medical, Inc. · Jun 2004
NVISION DATA MANAGEMENT SOFTWARE
K033307 · Nonin Medical, Inc. · May 2004
MASIMO SET INTELLIVUE PULSE OXIMETER MODULE
K040259 · Masimo Corp. · Apr 2004
MASIMO SET RAD-5V PULSE OXIMETER, MODEL RAD-5V
K033998 · Masimo Corp. · Mar 2004