Cleared Traditional

K852108 - NEWPORT VENTILATOR MODEL E-100

K852108 · Newport Medical Instruments, Inc. · Cardiovascular device
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Sep 1985
Decision
126d
Days
-
Risk

K852108 is an FDA 510(k) clearance for the NEWPORT VENTILATOR MODEL E-100.

Submitted by Newport Medical Instruments, Inc. (Newport Beach, US). The FDA issued a Cleared decision on September 18, 1985 after a review of 126 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel. 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 Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Newport Medical Instruments, Inc. devices

FDA 510(k) Submission Details - K852108

510(k) Number K852108 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 1985
Decision Date September 18, 1985
Days to Decision 126 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
1d slower than avg
Panel avg: 125d · This submission: 126d
Pathway characteristics
Predicate-based equivalence.

Device Classification - Class ,

Product Code -
Device Class -