Cleared Traditional

K954759 - FLOWMATE LTE

K954759 is an FDA 510(k) clearance for FLOWMATE LTE, manufactured by Spirometrics Medical Equipment Co.. The device is a Class 2 Anesthesiology device with product code BZG cleared through the Traditional 510(k) pathway after a 178-day FDA review.

K954759 · Spirometrics Medical Equipment Co. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1996
Decision
178d
Days
Class 2
Risk

K954759 is an FDA 510(k) clearance for the FLOWMATE LTE. Classified as Spirometer, Diagnostic (product code BZG), Class II - Special Controls.

Submitted by Spirometrics Medical Equipment Co. (Auburn, US). The FDA issued a Cleared decision on April 12, 1996 after a review of 178 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1840 - 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 Spirometrics Medical Equipment Co. devices

FDA 510(k) Submission Details - K954759

510(k) Number K954759 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 17, 1995
Decision Date April 12, 1996
Days to Decision 178 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
38d slower than avg
Panel avg: 140d · This submission: 178d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BZG Device Classification - Class 2, Special Controls

Product Code BZG Spirometer, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1840
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 - BZG Spirometer, Diagnostic

All 76
Devices cleared under the same product code (BZG) and FDA review panel - the closest regulatory comparables to K954759.
MICRODL DIARYCARD SPIROMETER
K965042 · Micro Direct, Inc. · Jun 1997
ASTHMA MONITOR
K960078 · Erich Jaeger, Inc. · Sep 1996
SPIROVISION SV-III PC BASED SPIROMETER KIT MICRO
K953948 · Futuremed America, Inc. · Jun 1996
PURITAN-BENNETT RENAISSANCE SPIROMETRY SYSTEMWITH THE OPTIONALRENAISSANCE DB DATA MANAGEMENTSOFTWARE
K944762 · Puritan Bennett Corp. · Dec 1994
L.A.P. II SPRIOMETRY SYSTEM
K932936 · Allied Healthcare Products, Inc. · Feb 1994
SENSORMEDICS MODEL 2200 PULMONARY FUNCTION LABS
K923988 · Sensor Medics Corp. · Oct 1993