Cleared Traditional

K162131 - ExSpiron 1Xi

K162131 is an FDA 510(k) clearance for ExSpiron 1Xi, 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 281-day FDA review.

K162131 · Respiratory Motion, Inc. · Anesthesiology device
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May 2017
Decision
281d
Days
Class 2
Risk

K162131 is an FDA 510(k) clearance for the ExSpiron 1Xi. 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 May 9, 2017 after a review of 281 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 - K162131

510(k) Number K162131 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 2016
Decision Date May 09, 2017
Days to Decision 281 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
141d slower than avg
Panel avg: 140d · This submission: 281d
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 28
Devices cleared under the same product code (BZK) and FDA review panel - the closest regulatory comparables to K162131.
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K192595 · Respiratory Motion · Dec 2019
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K983274 · Nellcor Puritan Bennett, Inc. · Dec 1998
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS311
K972086 · Alexander Mfg. Co. · Aug 1997