Cleared Traditional

K101995 - CAPNOSTREAM 20P WITH MASIMO SPO2 BOARD

K101995 is an FDA 510(k) clearance for CAPNOSTREAM 20P WITH MASIMO SPO2 BOARD, manufactured by Oridion Capnography, Inc.. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Traditional 510(k) pathway after a 181-day FDA review.

K101995 · Oridion Capnography, Inc. · Anesthesiology device
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Jan 2011
Decision
181d
Days
Class 2
Risk

K101995 is an FDA 510(k) clearance for the CAPNOSTREAM 20P WITH MASIMO SPO2 BOARD. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Oridion Capnography, Inc. (Needham, US). The FDA issued a Cleared decision on January 11, 2011 after a review of 181 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 Oridion Capnography, Inc. devices

FDA 510(k) Submission Details - K101995

510(k) Number K101995 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 2010
Decision Date January 11, 2011
Days to Decision 181 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
41d slower than avg
Panel avg: 140d · This submission: 181d
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 K101995.
TRUSIGNAL R SPO2 PEDITIP SENSOR
K103802 · GE Healthcare Finland Oy · Aug 2011
MASIMO RADICAL Y PULSE CO-OXIMETER
K110028 · Masimo Corporation · Mar 2011
ESSENTIAL MRI PATIENT MONITOR
K103700 · Invivo Corporation · Mar 2011
VITAL SIGNS MONITOR
K102835 · Edan Instruments, Inc. · Dec 2010
PULSE OXIMETER
K102350 · Nonin Medical, Inc. · Dec 2010
V-TRUST HANDHELD PULSE OXIMETER MODEL: TD-8201
K101012 · Taidoc Technology Corporation · Dec 2010