Cleared Traditional

K853039 - PRESSURE REGULATOR

K853039 is an FDA 510(k) clearance for PRESSURE REGULATOR, manufactured by Erie Medical. The device is a Class 1 Anesthesiology device with product code CAN cleared through the Traditional 510(k) pathway after a 266-day FDA review.

K853039 · Erie Medical · Anesthesiology device
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Apr 1986
Decision
266d
Days
Class 1
Risk

K853039 is an FDA 510(k) clearance for the PRESSURE REGULATOR. Classified as Regulator, Pressure, Gas Cylinder (product code CAN), Class I - General Controls.

Submitted by Erie Medical (Milwaukee, US). The FDA issued a Cleared decision on April 11, 1986 after a review of 266 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K853039

510(k) Number K853039 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 1985
Decision Date April 11, 1986
Days to Decision 266 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
126d slower than avg
Panel avg: 140d · This submission: 266d
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 26
Devices cleared under the same product code (CAN) and FDA review panel - the closest regulatory comparables to K853039.
OXYGEN THERAPY REGULATOR
K894302 · Modern Engineering Co., Inc. · Aug 1989
CONCOA PRESSURE REGULATORS
K893621 · Concoa Controls Corp. of America · Jul 1989
BE #1100 MOISTURE TRAP & BE #1102/50 DISP CANISTER
K884927 · Instrumentation Industries, Inc. · Jun 1989
DOWNS VPAP CIRCUIT
K852333 · Vital Signs, Inc. · Oct 1985
PRESSURE REGULATOR/Y CONNECTOR
K852649 · C.R. Bard, Inc. · Aug 1985
PORTABLE OXYGEN SYSTEM
K830844 · Puritan Bennett Corp. · May 1983
K853039 · PRESSURE REGULATOR
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