Cleared Special

K192595 - ExSpiron 2Xi

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

K192595 · Respiratory Motion · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K192595

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.

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 61
Devices cleared under the same product code (BZK) and FDA review panel - the closest regulatory comparables to K192595.
ElintMAX Respiratory Monitor (ElintMAX Monitor A1)
K260226 · Amptron Medical, Inc. · Sep 2026
BEACON Caresystem Model 00002144
K192584 · Mermaid Care A/S · Dec 2019
Gas Module 3
K180788 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Oct 2018
ExSpiron 1Xi
K173181 · Respiratory Motion, Inc. · Mar 2018
ExSpiron 1Xi
K162131 · Respiratory Motion, Inc. · May 2017
EXSPIRON 1XI
K130170 · Respiratory Motion, Inc. · May 2013
K192595 · ExSpiron 2Xi
Download PDF FDA Summary Respiratory Motion