Cleared Special

DRAEGER MICRO2+ AND MASIMO MINISAT (K032537) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K032537 · Draeger Medical Systems, Inc. · Anesthesiology device
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Nov 2003
Decision
99d
Days
Class 2
Risk

K032537 is an FDA 510(k) clearance for the DRAEGER MICRO2+ AND MASIMO MINISAT. 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 November 25, 2003 after a review of 99 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. 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. Standard predicate reliance. 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

Submission Details

510(k) Number K032537 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 2003
Decision Date November 25, 2003
Days to Decision 99 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 140d · This submission: 99d
Pathway characteristics
Modification to existing cleared device.

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 171
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K032537.
PULSE OXIMETER, MODEL PM-50
K061442 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Sep 2006
PM-50 PULSE OXIMETER
K052693 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Mar 2006
DATEX-OHMEDA S/5 NELLCOR COMPATIBLE SATURATION MODULE, E-NSAT
K052755 · Ge Healthcare · Oct 2005
SIEMENS MICRO2+ WITH VAI SOFTWARE
K030640 · Siemens Medical Solutions USA, Inc. · Jun 2003
SIEMENS MEDICAL INFORMATION BUS (MIB/MIB II/MIB DUO) PROTOCOL COVERTER
K022766 · Siemens Medical Solutions USA, Inc. · Sep 2002
DINAMAP PROCARE SERIES MONITOR, MODELS 100N, 200N, 300N, 400N
K022193 · Ge Medical Systems Information Technologies · Aug 2002