Cleared Traditional

K850740 - SECHRIST VOLUME VENTILATOR MODIFICATION (FDA 510(k) Clearance)

K850740 · Sechrist Industries, Inc. · Cardiovascular device
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Jul 1985
Decision
182d
Days
-
Risk

K850740 is an FDA 510(k) clearance for the SECHRIST VOLUME VENTILATOR MODIFICATION.

Submitted by Sechrist Industries, Inc. (Anaheim, US). The FDA issued a Cleared decision on July 29, 1985 after a review of 182 days - an extended review cycle.

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 Sechrist Industries, Inc. devices

Submission Details

510(k) Number K850740 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 28, 1985
Decision Date July 29, 1985
Days to Decision 182 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
57d slower than avg
Panel avg: 125d · This submission: 182d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -