Cleared Traditional

K091572 - DISPOSABLE SPO2 SENSOR M1134A

K091572 is an FDA 510(k) clearance for DISPOSABLE SPO2 SENSOR M1134A, manufactured by Philips Medizinsysteme Boeblingen GmbH, Cardiac AN. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K091572 · Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2009
Decision
112d
Days
Class 2
Risk

K091572 is an FDA 510(k) clearance for the DISPOSABLE SPO2 SENSOR M1134A. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Philips Medizinsysteme Boeblingen GmbH, Cardiac AN (Boeblingen, Baden-Wuerttemberg, DE). The FDA issued a Cleared decision on September 22, 2009 after a review of 112 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 Philips Medizinsysteme Boeblingen GmbH, Cardiac AN devices

FDA 510(k) Submission Details - K091572

510(k) Number K091572 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 2009
Decision Date September 22, 2009
Days to Decision 112 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
28d faster than avg
Panel avg: 140d · This submission: 112d
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 477
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K091572.
MASIMO SET RAD 8 PULSE OXIMETER AND ACCESSORIES, MODEL RAD 8
K092838 · Masimo Corporation · Oct 2009
MODEL 6000 TWO PARAMETER BEDSIDE MONITOR
K091787 · Ivy Biomedical Systems, Inc. · Oct 2009
EVISION DATA MANAGEMENT SOFTWARE
K092678 · Nonin Medical, Inc. · Oct 2009
CABLE, TRANSDUCER, MODEL 2400GN
K083448 · Conmed Corporation · Aug 2009
MASIMO SET REUSABLE SOFT OXIMETRY SENSORS - ADULT / PEDICATRICS, MODEL DBI/ DBIP
K090662 · Masimo Corporation · Aug 2009
MD300K1 PULSE OXIMETER
K090599 · Beijing Choice Electronic Technololgy Co., Ltd. · Jul 2009