Cleared Traditional

ExSpiron 1Xi (K173181) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through predicate-based substantial equivalence.

K173181 · Respiratory Motion, Inc. · Anesthesiology device
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Mar 2018
Decision
168d
Days
Class 2
Risk

K173181 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 March 16, 2018 after a review of 168 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

Submission Details

510(k) Number K173181 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2017
Decision Date March 16, 2018
Days to Decision 168 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
28d slower than avg
Panel avg: 140d · This submission: 168d
Pathway characteristics
Predicate-based equivalence.

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Anesthesiology devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT02336022 Completed Observational

The Evaluation of a Noninvasive Respiratory Monitor in Pediatric Patients Undergoing General Anesthesia

90
Patients (actual)
1
Site
Condition studied Respiratory Complications
Eligibility All sexes · 1 Year+
Principal investigator Viviane Nasr
Sponsor Boston Children's Hospital
Started 2015-03-01 → Primary completion 2016-05-01
Primary outcome
Respiratory rate accurately measured by the ExSpiron monitor during controlled ventilation.
Study completed - no results published. This trial concluded in 2016 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished.
View full study on ClinicalTrials.gov

Regulatory Peers - BZK Spirometer, Monitoring (w/wo Alarm)

All 8
Devices cleared under the same product code (BZK) and FDA review panel - the closest regulatory comparables to K173181.
BEACON Caresystem Model 00002144
K192584 · Mermaid Care A/S · Dec 2019
ExSpiron 2Xi
K192595 · Respiratory Motion · Dec 2019
Gas Module 3
K180788 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Oct 2018
GAS MODULE SE, MODEL 0998-00-0481-02
K062754 · Datascope Corp. · Nov 2006
OHMEDA 5410 VOLUME MONITOR
K862687 · Ohmeda Medical · Sep 1986
OHMEDA 5420 VOLUME MONITOR
K862688 · Ohmeda Medical · Sep 1986