Cleared Traditional

K893621 - CONCOA PRESSURE REGULATORS

K893621 is an FDA 510(k) clearance for CONCOA PRESSURE REGULATORS, manufactured by Concoa Controls Corp. of America. The device is a Class 1 Anesthesiology device with product code CAN cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K893621 · Concoa Controls Corp. of America · Anesthesiology device
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Jul 1989
Decision
78d
Days
Class 1
Risk

K893621 is an FDA 510(k) clearance for the CONCOA PRESSURE REGULATORS. Classified as Regulator, Pressure, Gas Cylinder (product code CAN), Class I - General Controls.

Submitted by Concoa Controls Corp. of America (Virginia Beach, US). The FDA issued a Cleared decision on July 28, 1989 after a review of 78 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.

FDA 510(k) Submission Details - K893621

510(k) Number K893621 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 1989
Decision Date July 28, 1989
Days to Decision 78 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
62d faster than avg
Panel avg: 140d · This submission: 78d
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 25
Devices cleared under the same product code (CAN) and FDA review panel - the closest regulatory comparables to K893621.
PURITAN-BENNETT OXYGEN PRESSURE REGULATOR W/FLOW.
K896152 · Puritan Bennett Corp. · Jan 1990
8053 TWO STAGE TYPE A-B NITROUS OXIDE THERAPY CYLI
K894850 · Modern Engineering Co., Inc. · Aug 1989
OXYGEN THERAPY REGULATOR
K894302 · Modern Engineering Co., Inc. · Aug 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
K893621 · CONCOA PRESSURE REGULATORS
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