Cleared Special

K061329 - INFINITY MASIMO SET SP02 POD

K061329 is an FDA 510(k) clearance for INFINITY MASIMO SET SP02 POD, manufactured by Draeger Medical Systems, Inc.. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Special 510(k) pathway after a 56-day FDA review.

K061329 · Draeger Medical Systems, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2006
Decision
56d
Days
Class 2
Risk

K061329 is an FDA 510(k) clearance for the INFINITY MASIMO SET SP02 POD. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Draeger Medical Systems, Inc. (Danvers, US). The FDA issued a Cleared decision on July 7, 2006 after a review of 56 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 870.2700 - the FDA anesthesiology and respiratory device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Draeger Medical Systems, Inc. devices

FDA 510(k) Submission Details - K061329

510(k) Number K061329 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 2006
Decision Date July 07, 2006
Days to Decision 56 days
Submission Type Special
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
84d faster than avg
Panel avg: 140d · This submission: 56d
Pathway characteristics
Modification to existing cleared device.

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 453
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K061329.
PULSE OXIMETER, MODEL PM-50
K061442 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Sep 2006
NELLCOR OXIMAX N-600X PULSE OXIMETER
K060576 · Nellcor Puritan Bennett, Inc. · Aug 2006
MASIMO SET RADICAL 7 PULSE CO-OXIMETER
K061204 · Masimo Corporation · Jul 2006
LNCS AND SPO2.COM SENSORS
K060143 · Masimo Corporation · Jun 2006
WELCH ALLYN CONNEX VITAL SOLUTIONS SOFTWARE
K053381 · Welch Allyn, Inc. · Jun 2006
CONMED PRO2 PULSE REFLECTANCE OXIMETER, MODEL PRO-M
K061112 · Conmed Corporation · May 2006