Cleared Traditional

K810679 - MS-303-OXYGEN REGULATOR SHIELD

K810679 is an FDA 510(k) clearance for MS-303-OXYGEN REGULATOR SHIELD, manufactured by Instrumentation Industries, Inc.. The device is a Class 1 Anesthesiology device with product code CAN cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K810679 · Instrumentation Industries, Inc. · Anesthesiology device
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Apr 1981
Decision
35d
Days
Class 1
Risk

K810679 is an FDA 510(k) clearance for the MS-303-OXYGEN REGULATOR SHIELD. Classified as Regulator, Pressure, Gas Cylinder (product code CAN), Class I - General Controls.

Submitted by Instrumentation Industries, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 17, 1981 after a review of 35 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 Instrumentation Industries, Inc. devices

FDA 510(k) Submission Details - K810679

510(k) Number K810679 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 1981
Decision Date April 17, 1981
Days to Decision 35 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
105d faster than avg
Panel avg: 140d · This submission: 35d
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 16
Devices cleared under the same product code (CAN) and FDA review panel - the closest regulatory comparables to K810679.
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
REGULATOR, OXYGEN MECHANICAL
K803207 · Timeter Instrument Corp. · Jan 1981
EMERG. OXYGEN KIT #65350 & #65399 CASE
K802644 · B & F Medical Products, Inc. · Dec 1980
PORT-A-BOUT 240
K772216 · Hudson Oxygen Therapy Sales Co. · Jan 1978