Cleared Traditional

3M VOLUME VENTIATOR CIRCUIT (K820131) - FDA 510(k) Clearance

Class I Anesthesiology device.

K820131 · 3M Company · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1982
Decision
10d
Days
Class 1
Risk

K820131 is an FDA 510(k) clearance for the 3M VOLUME VENTIATOR CIRCUIT. Classified as Set, Tubing And Support, Ventilator (w Harness) (product code BZO), Class I - General Controls.

Submitted by 3M Company (Monrovia, US). The FDA issued a Cleared decision on January 28, 1982 after a review of 10 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5975 - 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 3M Company devices

Submission Details

510(k) Number K820131 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 18, 1982
Decision Date January 28, 1982
Days to Decision 10 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
130d faster than avg
Panel avg: 140d · This submission: 10d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code BZO Set, Tubing And Support, Ventilator (w Harness)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5975
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - BZO Set, Tubing And Support, Ventilator (w Harness)

Devices cleared under the same product code (BZO) and FDA review panel - the closest regulatory comparables to K820131.
PORTABLE VENTILATOR PATIENT CIRCUIT
K873900 · Puritan Bennett Corp. · Oct 1987
MODUFLEX NEONATAL VENTILATOR SET
K823479 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1982
INSPIRON NEONATAL VENTILATOR CIRCUIT
K821064 · C.R. Bard, Inc. · May 1982
PEDIATRIC VENTILATOR CIRCUIT 2C7131
K813155 · Travenol Laboratories, S.A. · Dec 1981
RAIN-X
K791060 · Sherwood Medical Co. · Jun 1979