Cleared Traditional

K915154 - GAMBRO ENGSTROM Y FILTER PKG. ALONE W/ VAR.MODELS (FDA 510(k) Clearance)

Class I Anesthesiology device.

K915154 · C.G.H. Medical, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1992
Decision
195d
Days
Class 1
Risk

K915154 is an FDA 510(k) clearance for the GAMBRO ENGSTROM Y FILTER PKG. ALONE W/ VAR.MODELS. Classified as Regulator, Pressure, Gas Cylinder (product code CAN), Class I - General Controls.

Submitted by C.G.H. Medical, Inc. (Lakewood, US). The FDA issued a Cleared decision on May 27, 1992 after a review of 195 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 C.G.H. Medical, Inc. devices

Submission Details

510(k) Number K915154 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 1991
Decision Date May 27, 1992
Days to Decision 195 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
56d slower than avg
Panel avg: 139d · This submission: 195d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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.