Cleared Traditional

K803207 - REGULATOR, OXYGEN MECHANICAL

K803207 is an FDA 510(k) clearance for REGULATOR, manufactured by Timeter Instrument Corp.. The device is a Class 1 Anesthesiology device with product code CAN cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K803207 · Timeter Instrument Corp. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1981
Decision
28d
Days
Class 1
Risk

K803207 is an FDA 510(k) clearance for the REGULATOR, OXYGEN MECHANICAL. Classified as Regulator, Pressure, Gas Cylinder (product code CAN), Class I - General Controls.

Submitted by Timeter Instrument Corp. (Mchenry, US). The FDA issued a Cleared decision on January 15, 1981 after a review of 28 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 Timeter Instrument Corp. devices

FDA 510(k) Submission Details - K803207

510(k) Number K803207 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 1980
Decision Date January 15, 1981
Days to Decision 28 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
112d faster than avg
Panel avg: 140d · This submission: 28d
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 15
Devices cleared under the same product code (CAN) and FDA review panel - the closest regulatory comparables to K803207.
PRESSURE REGULATOR/Y CONNECTOR
K852649 · C.R. Bard, Inc. · Aug 1985
PORTABLE OXYGEN SYSTEM
K830844 · Puritan Bennett Corp. · May 1983
MS-303-OXYGEN REGULATOR SHIELD
K810679 · Instrumentation Industries, Inc. · Apr 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