Cleared Traditional

K896120 - SCHILLER MODEL SP-100 SPIROVIT(TM)

K896120 is an FDA 510(k) clearance for SCHILLER MODEL SP-100 SPIROVIT(TM), manufactured by Schiller America, Inc.. The device is a Class 2 Anesthesiology device with product code BZG cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K896120 · Schiller America, Inc. · Anesthesiology device
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Jan 1990
Decision
77d
Days
Class 2
Risk

K896120 is an FDA 510(k) clearance for the SCHILLER MODEL SP-100 SPIROVIT(TM). Classified as Spirometer, Diagnostic (product code BZG), Class II - Special Controls.

Submitted by Schiller America, Inc. (Tustin, US). The FDA issued a Cleared decision on January 9, 1990 after a review of 77 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.

FDA 510(k) Submission Details - K896120

510(k) Number K896120 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 24, 1989
Decision Date January 09, 1990
Days to Decision 77 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 140d · This submission: 77d
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 190
Devices cleared under the same product code (BZG) and FDA review panel - the closest regulatory comparables to K896120.
WRIGHT VENTILOMETER VM-1
K895953 · Clement Clarke, Inc. · Feb 1990
MODIFIED SPIROSCAN 1000
K897094 · Fukuda Denshi USA, Inc. · Jan 1990
SPIROTEQ
K894556 · System Analysis Corp. · Jan 1990
SCHILLER MODEL SP-200 SPIROVIT(TM)
K896121 · Schiller America, Inc. · Jan 1990
MULTISPIRO
K895375 · Medical Equipment Designs, Inc. · Nov 1989
PNEUMOCHECK W/PRINTER/CHARGER AND ACCESSORIES
K895253 · Welch Allyn, Inc. · Nov 1989
K896120 · SCHILLER MODEL SP-100 SPIROVIT(TM)
Download PDF Schiller America, Inc.