Cleared Traditional

AIR BUBBLE DETECTOR (K781021) - FDA 510(k) Clearance

K781021 · 3M Health Care, Sarns · Cardiovascular device
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Sep 1978
Decision
100d
Days
-
Risk

K781021 is an FDA 510(k) clearance for the AIR BUBBLE DETECTOR.

Submitted by 3M Health Care, Sarns (Mchenry, US). The FDA issued a Cleared decision on September 27, 1978 after a review of 100 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 3M Health Care, Sarns devices

Submission Details

510(k) Number K781021 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 1978
Decision Date September 27, 1978
Days to Decision 100 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 125d · This submission: 100d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -