Cleared Traditional

K834061 - SLO-FLO 40AL ADJUST-FLOW REGULATOR

K834061 is an FDA 510(k) clearance for SLO-FLO 40AL ADJUST-FLOW REGULATOR, manufactured by S.L.O. Health Products, Inc.. The device is a Class 1 Anesthesiology device with product code CAN cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K834061 · S.L.O. Health Products, Inc. · Anesthesiology device
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Jan 1984
Decision
46d
Days
Class 1
Risk

K834061 is an FDA 510(k) clearance for the SLO-FLO 40AL ADJUST-FLOW REGULATOR. Classified as Regulator, Pressure, Gas Cylinder (product code CAN), Class I - General Controls.

Submitted by S.L.O. Health Products, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 10, 1984 after a review of 46 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 - K834061

510(k) Number K834061 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 1983
Decision Date January 10, 1984
Days to Decision 46 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
94d faster than avg
Panel avg: 140d · This submission: 46d
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 K834061.
BE #1100 MOISTURE TRAP & BE #1102/50 DISP CANISTER
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DOWNS VPAP CIRCUIT
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PORTABLE OXYGEN SYSTEM
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MS-303-OXYGEN REGULATOR SHIELD
K810679 · Instrumentation Industries, Inc. · Apr 1981
REGULATOR, OXYGEN MECHANICAL
K803207 · Timeter Instrument Corp. · Jan 1981
K834061 · SLO-FLO 40AL ADJUST-FLOW REGULATOR
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