Cleared Traditional

K060265 - REMCORE REMOTE CONTROLLED OXYGEN REGULATOR

K060265 is an FDA 510(k) clearance for REMCORE REMOTE CONTROLLED OXYGEN REGULATOR, manufactured by Remcore, Inc.. 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.

K060265 · Remcore, Inc. · Anesthesiology device
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Oct 2006
Decision
266d
Days
Class 1
Risk

K060265 is an FDA 510(k) clearance for the REMCORE REMOTE CONTROLLED OXYGEN REGULATOR. Classified as Regulator, Pressure, Gas Cylinder (product code CAN), Class I - General Controls.

Submitted by Remcore, Inc. (Boston, US). The FDA issued a Cleared decision on October 25, 2006 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.

View all Remcore, Inc. devices

FDA 510(k) Submission Details - K060265

510(k) Number K060265 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 2006
Decision Date October 25, 2006
Days to Decision 266 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
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 15
Devices cleared under the same product code (CAN) and FDA review panel - the closest regulatory comparables to K060265.
VANGUARD SERIES GAS REGULATORS
K942751 · Buckman Co., Inc. · Feb 1995
LSPI PRESSURE REGULATOR
K936187 · Life Support Products, Inc. · Jan 1994
1500 SERIES REGULATOR
K932006 · Precision Medical, Inc. · Oct 1993
SALTER LABS DISPOSABLE NIPPLE AND NUT
K912174 · Salter Labs · Jul 1991
PRECISION MEDICAL OXYGEN REGULATOR
K901831 · Precision Medical, Inc. · Aug 1990
VENTLAB EXHALATION MANIFOLD VX-2000 A & VX-2000 B
K900115 · Ventlab Corp. · Feb 1990