Cleared Traditional

K823770 - SPIROTECH ST-5500

K823770 is an FDA 510(k) clearance for SPIROTECH ST-5500, manufactured by Spirotech, Inc.. The device is a Class 2 Anesthesiology device with product code BZG cleared through the Traditional 510(k) pathway after a 171-day FDA review.

K823770 · Spirotech, Inc. · Anesthesiology device
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Jun 1983
Decision
171d
Days
Class 2
Risk

K823770 is an FDA 510(k) clearance for the SPIROTECH ST-5500. Classified as Spirometer, Diagnostic (product code BZG), Class II - Special Controls.

Submitted by Spirotech, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 3, 1983 after a review of 171 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.

FDA 510(k) Submission Details - K823770

510(k) Number K823770 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 1982
Decision Date June 03, 1983
Days to Decision 171 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
31d slower than avg
Panel avg: 140d · This submission: 171d
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 184
Devices cleared under the same product code (BZG) and FDA review panel - the closest regulatory comparables to K823770.
ERGO-OXYSCREEN
K843841 · Erich Jaeger, Inc. · Dec 1984
PULMONARY FUNCTION SYSTEM
K842041 · Sensor Medics Corp. · Jun 1984
RESPIRODYNE PULMONARY FUNCTION TEST
K834475 · Chesebrough-Pond'S U.S.A. Co. · Feb 1984
BREATH METER
K810437 · Fred Sammons, Inc. · May 1981
DISPIRO
K791177 · Utah Medical Products, Inc. · Aug 1979
K823770 · SPIROTECH ST-5500
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