Cleared Traditional

K950777 - OXYGEN REGULATOR

K950777 is an FDA 510(k) clearance for OXYGEN REGULATOR, manufactured by Mada Medical Products, Inc.. The device is a Class 1 Anesthesiology device with product code CAN cleared through the Traditional 510(k) pathway after a 52-day FDA review.

K950777 · Mada Medical Products, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1995
Decision
52d
Days
Class 1
Risk

K950777 is an FDA 510(k) clearance for the OXYGEN REGULATOR. Classified as Regulator, Pressure, Gas Cylinder (product code CAN), Class I - General Controls.

Submitted by Mada Medical Products, Inc. (Carlstadt, US). The FDA issued a Cleared decision on April 14, 1995 after a review of 52 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 - K950777

510(k) Number K950777 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 1995
Decision Date April 14, 1995
Days to Decision 52 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
88d faster than avg
Panel avg: 140d · This submission: 52d
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 54
Devices cleared under the same product code (CAN) and FDA review panel - the closest regulatory comparables to K950777.
PORTABLE OXYGEN UNIT SCA900
K080243 · San Cheong Co. , Ltd. · Apr 2009
REMCORE REMOTE CONTROLLED OXYGEN REGULATOR
K060265 · Remcore, Inc. · Oct 2006
CYL-FIL OXYGEN SYSTEM
K061785 · Responsive Respiratory, Inc. · Sep 2006
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
K950777 · OXYGEN REGULATOR
Download PDF Mada Medical Products…