Cleared Traditional

K984031 - SPIROVIT

K984031 is an FDA 510(k) clearance for SPIROVIT, manufactured by Schiller AG. The device is a Class 2 Anesthesiology device with product code BZG cleared through the Traditional 510(k) pathway after a 169-day FDA review.

K984031 · Schiller AG · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1999
Decision
169d
Days
Class 2
Risk

K984031 is an FDA 510(k) clearance for the SPIROVIT, MODEL SP-250. Classified as Spirometer, Diagnostic (product code BZG), Class II - Special Controls.

Submitted by Schiller AG (Baar, CH). The FDA issued a Cleared decision on April 30, 1999 after a review of 169 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 Schiller AG devices

FDA 510(k) Submission Details - K984031

510(k) Number K984031 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 1998
Decision Date April 30, 1999
Days to Decision 169 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
29d slower than avg
Panel avg: 140d · This submission: 169d
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 51
Devices cleared under the same product code (BZG) and FDA review panel - the closest regulatory comparables to K984031.
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K013123 · Engineered Medical Systems · Mar 2002
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K980441 · Nellcor Puritan Bennett, Inc. · Apr 1998
ASTHMA MONITOR
K960078 · Erich Jaeger, Inc. · Sep 1996
PURITAN-BENNETT RENAISSANCE SPIROMETRY SYSTEMWITH THE OPTIONALRENAISSANCE DB DATA MANAGEMENTSOFTWARE
K944762 · Puritan Bennett Corp. · Dec 1994