Cleared Traditional

K091853 - WRIGHT RESPIROMETER

K091853 is an FDA 510(k) clearance for WRIGHT RESPIROMETER, manufactured by Nspire Health, Inc.. The device is a Class 2 Anesthesiology device with product code BZK cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K091853 · Nspire Health, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2009
Decision
90d
Days
Class 2
Risk

K091853 is an FDA 510(k) clearance for the WRIGHT RESPIROMETER, MARK 8, AND 14 RESPIROMETER, MODEL 700-021, 700-008, 700.... Classified as Spirometer, Monitoring (w/wo Alarm) (product code BZK), Class II - Special Controls.

Submitted by Nspire Health, Inc. (Longmont, US). The FDA issued a Cleared decision on September 21, 2009 after a review of 90 days - within the typical 510(k) review window.

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 Nspire Health, Inc. devices

FDA 510(k) Submission Details - K091853

510(k) Number K091853 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 2009
Decision Date September 21, 2009
Days to Decision 90 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
50d faster than avg
Panel avg: 140d · This submission: 90d
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 29
Devices cleared under the same product code (BZK) and FDA review panel - the closest regulatory comparables to K091853.
ExSpiron 2Xi
K192595 · Respiratory Motion · Dec 2019
Gas Module 3
K180788 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Oct 2018
ExSpiron 1Xi
K173181 · Respiratory Motion, Inc. · Mar 2018
GAS MODULE SE, MODEL 0998-00-0481-02
K062754 · Datascope Corp. · Nov 2006
STARTRACK INFANT GRAPHICS MONITOR
K983274 · Nellcor Puritan Bennett, Inc. · Dec 1998
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS311
K972086 · Alexander Mfg. Co. · Aug 1997