Cleared Traditional

K821064 - INSPIRON NEONATAL VENTILATOR CIRCUIT

K821064 is an FDA 510(k) clearance for INSPIRON NEONATAL VENTILATOR CIRCUIT, manufactured by C.R. Bard, Inc.. The device is a Class 1 Anesthesiology device with product code BZO cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K821064 · C.R. Bard, Inc. · Anesthesiology device
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May 1982
Decision
18d
Days
Class 1
Risk

K821064 is an FDA 510(k) clearance for the INSPIRON NEONATAL VENTILATOR CIRCUIT. Classified as Set, Tubing And Support, Ventilator (w Harness) (product code BZO), Class I - General Controls.

Submitted by C.R. Bard, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 3, 1982 after a review of 18 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 C.R. Bard, Inc. devices

FDA 510(k) Submission Details - K821064

510(k) Number K821064 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 1982
Decision Date May 03, 1982
Days to Decision 18 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
122d faster than avg
Panel avg: 140d · This submission: 18d
Pathway characteristics
Predicate-based equivalence.

BZO Device Classification - Class 1, General Controls

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)

All 32
Devices cleared under the same product code (BZO) and FDA review panel - the closest regulatory comparables to K821064.
UNIVERSAL VOL. VENTILATOR 72 #1626
K832681 · Hudson Oxygen Therapy Sales Co. · Sep 1983
BE #16 - MANIFOLD
K823481 · Instrumentation Industries, Inc. · Dec 1982
MODUFLEX NEONATAL VENTILATOR SET
K823479 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1982
3M VOLUME VENTIATOR CIRCUIT
K820131 · 3M Company · Jan 1982
PEDIATRIC VENTILATOR CIRCUIT 2C7131
K813155 · Travenol Laboratories, S.A. · Dec 1981
VENTILATOR CIRCUIT
K812774 · Hudson Oxygen Therapy Sales Co. · Oct 1981