Cleared Special

K192595 - ExSpiron 2Xi

K192595 is the FDA 510(k) clearance for ExSpiron 2Xi by Respiratory Motion. It is a Class 2 Anesthesiology device (product code BZK) cleared through the Special 510(k) pathway after a 88-day FDA review.

K192595 · Respiratory Motion · Anesthesiology device
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Dec 2019
Decision
88d
Days
Class 2
Risk

K192595 is an FDA 510(k) clearance for the ExSpiron 2Xi. Classified as Spirometer, Monitoring (w/wo Alarm) (product code BZK), Class II - Special Controls.

Submitted by Respiratory Motion (Watertown, US). The FDA issued a Cleared decision on December 17, 2019 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1850 - 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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Respiratory Motion devices

Submission Details

510(k) Number K192595 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 2019
Decision Date December 17, 2019
Days to Decision 88 days
Submission Type Special
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
52d faster than avg
Panel avg: 140d · This submission: 88d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 14
Devices cleared under the same product code (BZK) and FDA review panel - the closest regulatory comparables to K192595.
BEACON Caresystem Model 00002144
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CAPNOMAC ULTIMA ANESTHESIA MONITOR
K932098 · Datex Division Instrumentarium Corp. · Nov 1993
OHMEDA 5410 VOLUME MONITOR
K862687 · Ohmeda Medical · Sep 1986