Cleared Traditional

K852649 - PRESSURE REGULATOR/Y CONNECTOR

K852649 is an FDA 510(k) clearance for PRESSURE REGULATOR/Y CONNECTOR, manufactured by C.R. Bard, Inc.. The device is a Class 1 Anesthesiology device with product code CAN cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K852649 · C.R. Bard, Inc. · Anesthesiology device
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Aug 1985
Decision
42d
Days
Class 1
Risk

K852649 is an FDA 510(k) clearance for the PRESSURE REGULATOR/Y CONNECTOR. Classified as Regulator, Pressure, Gas Cylinder (product code CAN), Class I - General Controls.

Submitted by C.R. Bard, Inc. (Murray Hill, US). The FDA issued a Cleared decision on August 2, 1985 after a review of 42 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.2700 - 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 - K852649

510(k) Number K852649 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 1985
Decision Date August 02, 1985
Days to Decision 42 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
98d faster than avg
Panel avg: 140d · This submission: 42d
Pathway characteristics
Predicate-based equivalence.

CAN Device Classification - Class 1, General Controls

Product Code CAN Regulator, Pressure, Gas Cylinder
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.2700
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 - CAN Regulator, Pressure, Gas Cylinder

All 14
Devices cleared under the same product code (CAN) and FDA review panel - the closest regulatory comparables to K852649.
PURITAN-BENNETT OXYGEN PRESSURE REGULATOR W/FLOW.
K896152 · Puritan Bennett Corp. · Jan 1990
BE #1100 MOISTURE TRAP & BE #1102/50 DISP CANISTER
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DOWNS VPAP CIRCUIT
K852333 · Vital Signs, Inc. · Oct 1985
PORTABLE OXYGEN SYSTEM
K830844 · Puritan Bennett Corp. · May 1983
MS-303-OXYGEN REGULATOR SHIELD
K810679 · Instrumentation Industries, Inc. · Apr 1981
REGULATOR, OXYGEN MECHANICAL
K803207 · Timeter Instrument Corp. · Jan 1981