Cleared Traditional

K861227 - COLLINS PNEUMOTACH PFT SYSTEM

K861227 is an FDA 510(k) clearance for COLLINS PNEUMOTACH PFT SYSTEM, manufactured by Warren E. Collins, Inc.. The device is a Class 2 Anesthesiology device with product code BZG cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K861227 · Warren E. Collins, Inc. · Anesthesiology device
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Jun 1986
Decision
65d
Days
Class 2
Risk

K861227 is an FDA 510(k) clearance for the COLLINS PNEUMOTACH PFT SYSTEM. Classified as Spirometer, Diagnostic (product code BZG), Class II - Special Controls.

Submitted by Warren E. Collins, Inc. (Braintree, US). The FDA issued a Cleared decision on June 5, 1986 after a review of 65 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 Warren E. Collins, Inc. devices

FDA 510(k) Submission Details - K861227

510(k) Number K861227 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 1986
Decision Date June 05, 1986
Days to Decision 65 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
75d faster than avg
Panel avg: 140d · This submission: 65d
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 130
Devices cleared under the same product code (BZG) and FDA review panel - the closest regulatory comparables to K861227.
VITALOGRAPH-ALPHA
K873562 · Vitalograph , Ltd. · Aug 1988
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
MODEL 2120 SPIROSCREEN
K854403 · Gould, Inc. · Jan 1986
VITALOGRAPH COMPACT
K854526 · Vitalograph , Ltd. · Dec 1985