Cleared Traditional

K781021 - AIR BUBBLE DETECTOR

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

FDA 510(k) Submission Details - K781021

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 125d · This submission: 100d
Pathway characteristics
Predicate-based equivalence.

Device Classification - Class ,

Product Code -
Device Class -