Cleared Traditional

K864095 - ENGSTROM EDITH MODELS 500

K864095 is an FDA 510(k) clearance for ENGSTROM EDITH MODELS 500, manufactured by Gambro, Inc.. The device is a Class 1 Anesthesiology device with product code BYD cleared through the Traditional 510(k) pathway after a 122-day FDA review.

K864095 · Gambro, Inc. · Anesthesiology device
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Feb 1987
Decision
122d
Days
Class 1
Risk

K864095 is an FDA 510(k) clearance for the ENGSTROM EDITH MODELS 500,1000,1500 & 1500F. Classified as Condenser, Heat And Moisture (artificial Nose) (product code BYD), Class I - General Controls.

Submitted by Gambro, Inc. (Lincolnshire, US). The FDA issued a Cleared decision on February 20, 1987 after a review of 122 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5375 - 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 Gambro, Inc. devices

FDA 510(k) Submission Details - K864095

510(k) Number K864095 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 1986
Decision Date February 20, 1987
Days to Decision 122 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
18d faster than avg
Panel avg: 140d · This submission: 122d
Pathway characteristics
Predicate-based equivalence.

BYD Device Classification - Class 1, General Controls

Product Code BYD Condenser, Heat And Moisture (artificial Nose)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5375
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 - BYD Condenser, Heat And Moisture (artificial Nose)

All 24
Devices cleared under the same product code (BYD) and FDA review panel - the closest regulatory comparables to K864095.
BREATHE EASY
K914336 · Vital Signs, Inc. · Mar 1992
INTERTECH(TM) HEAT AND MOISTURE EXCHANGER
K903519 · Intertech Resources, Inc. · Dec 1990
HUMIDI-FLEX TM
K885313 · Life Design Systems, Inc. · Oct 1989
AMERICAN PHARMASEAL HUMIDAIR CONDENSER
K854012 · American Pharmaseal Div. Ahsc · Dec 1985
SERVO HUMIDIFIER 153
K852601 · Siemens Elema AB · Jul 1985
SERVO HUMIDIFIER 152 SIEMENS-ELEMA AB
K844040 · Siemens Elema AB · Oct 1984