Cleared Abbreviated

K101600 - INTELLIVUE CL SP02 POD MODEL 865215, INTELLIVUE CL NBP POD MODEL 865216, INTELLIVUE PATIENT MONITORS MP5, MP2, X2 MODEL

K101600 is an FDA 510(k) clearance for INTELLIVUE CL SP02 POD MODEL 865215, manufactured by Philips Medizinsysteme Boeblingen GmbH, Cardiac AN. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Abbreviated 510(k) pathway after a 84-day FDA review.

K101600 · Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2010
Decision
84d
Days
Class 2
Risk

K101600 is an FDA 510(k) clearance for the INTELLIVUE CL SP02 POD MODEL 865215, INTELLIVUE CL NBP POD MODEL 865216, INTE.... 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 August 31, 2010 after a review of 84 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. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

FDA 510(k) Submission Details - K101600

510(k) Number K101600 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 2010
Decision Date August 31, 2010
Days to Decision 84 days
Submission Type Abbreviated
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
56d faster than avg
Panel avg: 140d · This submission: 84d
Pathway characteristics
Standards-based clearance path.

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 687
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K101600.
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K100403 · Masimo Corporation · Jun 2010
OXIBLUE FINGERTIP PULSE OXIMETER MODEL MD300C318, OXIPRO FINGERTIP PULSE OXIMETER MODEL MD300C316
K100815 · Oxypulse · Jun 2010