Cleared Traditional

K120087 - EXSPIRON

K120087 is an FDA 510(k) clearance for EXSPIRON, manufactured by Respiratory Motion, Inc.. The device is a Class 2 Anesthesiology device with product code BZK cleared through the Traditional 510(k) pathway after a 259-day FDA review.

K120087 · Respiratory Motion, Inc. · Anesthesiology device
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Sep 2012
Decision
259d
Days
Class 2
Risk

K120087 is an FDA 510(k) clearance for the EXSPIRON. Classified as Spirometer, Monitoring (w/wo Alarm) (product code BZK), Class II - Special Controls.

Submitted by Respiratory Motion, Inc. (Waltham, US). The FDA issued a Cleared decision on September 26, 2012 after a review of 259 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1850 - 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 Respiratory Motion, Inc. devices

FDA 510(k) Submission Details - K120087

510(k) Number K120087 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 11, 2012
Decision Date September 26, 2012
Days to Decision 259 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
119d slower than avg
Panel avg: 140d · This submission: 259d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BZK Device Classification - Class 2, Special Controls

Product Code BZK Spirometer, Monitoring (w/wo Alarm)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1850
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 - BZK Spirometer, Monitoring (w/wo Alarm)

All 38
Devices cleared under the same product code (BZK) and FDA review panel - the closest regulatory comparables to K120087.
ExSpiron 1Xi
K173181 · Respiratory Motion, Inc. · Mar 2018
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EXSPIRON 1XI
K130170 · Respiratory Motion, Inc. · May 2013
PHILIPS NM3 RESPIRATORY MONITOR WITH VENTASSIST
K103578 · Respironics Novametrix, LLC · Jun 2011
WRIGHT RESPIROMETER, MARK 8, AND 14 RESPIROMETER, MODEL 700-021, 700-008, 700-014
K091853 · Nspire Health, Inc. · Sep 2009
MERCURY VCO2
K092217 · Respironics Novametrix, Inc. · Aug 2009