Cleared Traditional

K854403 - MODEL 2120 SPIROSCREEN

K854403 is an FDA 510(k) clearance for MODEL 2120 SPIROSCREEN, manufactured by Gould, Inc.. The device is a Class 2 Anesthesiology device with product code BZG cleared through the Traditional 510(k) pathway after a 75-day FDA review.

K854403 · Gould, Inc. · Anesthesiology device
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Jan 1986
Decision
75d
Days
Class 2
Risk

K854403 is an FDA 510(k) clearance for the MODEL 2120 SPIROSCREEN. Classified as Spirometer, Diagnostic (product code BZG), Class II - Special Controls.

Submitted by Gould, Inc. (Dayton, US). The FDA issued a Cleared decision on January 14, 1986 after a review of 75 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 Gould, Inc. devices

FDA 510(k) Submission Details - K854403

510(k) Number K854403 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 1985
Decision Date January 14, 1986
Days to Decision 75 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
65d faster than avg
Panel avg: 140d · This submission: 75d
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 69
Devices cleared under the same product code (BZG) and FDA review panel - the closest regulatory comparables to K854403.
SPIRO ANALYZER ST-300
K873817 · Futuremed Div. of Future Impex Corp. · Dec 1987
SALTER VOLUCHEK 6600
K863656 · Salter Labs · Oct 1986
SCREENMATE
K853409 · Erich Jaeger, Inc. · Feb 1986
VITALOGRAPH COMPACT
K854526 · Vitalograph , Ltd. · Dec 1985
PALL PULMONARY FUNCTION FILTER
K854062 · Pall Biomedical Products Co. · Nov 1985
PB900 PB910 DIAGNOSTIC SPIROMETER
K852092 · Puritan Bennett Corp. · Jul 1985