Cleared Traditional

K963035 - MICRO SPIROMETER

K963035 is an FDA 510(k) clearance for MICRO SPIROMETER, manufactured by Micro Direct, Inc.. The device is a Class 2 Anesthesiology device with product code BZG cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K963035 · Micro Direct, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1996
Decision
88d
Days
Class 2
Risk

K963035 is an FDA 510(k) clearance for the MICRO SPIROMETER. Classified as Spirometer, Diagnostic (product code BZG), Class II - Special Controls.

Submitted by Micro Direct, Inc. (Auburn, US). The FDA issued a Cleared decision on November 1, 1996 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1840 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Micro Direct, Inc. devices

FDA 510(k) Submission Details - K963035

510(k) Number K963035 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 1996
Decision Date November 01, 1996
Days to Decision 88 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
52d faster than avg
Panel avg: 140d · This submission: 88d
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 70
Devices cleared under the same product code (BZG) and FDA review panel - the closest regulatory comparables to K963035.
SPIROBANK PORTABLE PC BASED SPIROMETER
K973456 · Futuremed America, Inc. · Jul 1998
SPIROMETER MODEL NPB-500
K980441 · Nellcor Puritan Bennett, Inc. · Apr 1998
MICRODL DIARYCARD SPIROMETER
K965042 · Micro Direct, Inc. · Jun 1997
ASTHMA MONITOR
K960078 · Erich Jaeger, Inc. · Sep 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