Cleared Traditional

K852407 - SENSOR TAPE CAT. NO. ST-45

K852407 is the FDA 510(k) clearance for SENSOR TAPE CAT. NO. ST-45 by American Omni Medical, Inc.. It is a Class 2 Cardiovascular device (product code DTW) cleared through the Traditional 510(k) pathway after a 137-day FDA review.

K852407 · American Omni Medical, Inc. · Cardiovascular device
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Oct 1985
Decision
137d
Days
Class 2
Risk

K852407 is an FDA 510(k) clearance for the SENSOR TAPE CAT. NO. ST-45. Classified as Monitor And/or Control, Level Sensing, Cardiopulmonary Bypass (product code DTW), Class II - Special Controls.

Submitted by American Omni Medical, Inc. (Costa Mesa, US). The FDA issued a Cleared decision on October 21, 1985 after a review of 137 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4340 - the FDA cardiovascular device oversight 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 Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all American Omni Medical, Inc. devices

Submission Details

510(k) Number K852407 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 06, 1985
Decision Date October 21, 1985
Days to Decision 137 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
12d slower than avg
Panel avg: 125d · This submission: 137d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DTW Monitor And/or Control, Level Sensing, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4340
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DTW Monitor And/or Control, Level Sensing, Cardiopulmonary Bypass

All 9
Devices cleared under the same product code (DTW) and FDA review panel - the closest regulatory comparables to K852407.
COBE AIR EMBOLI PROTECTION SYSTEM (AEPS)
K900910 · Cobe Laboratories, Inc. · May 1990
SARNS 9000 PERFUSION SYSTEM W/ALERT ONLY LEVEL
K900815 · 3M Company · May 1990
GAMBRO ULTRASONIC BLOOD LEVEL DETECTOR ULD 10-200
K860076 · Gambro, Inc. · May 1986
STOCKERT-SHILEY UNIVERSAL LEVEL SENSOR
K843802 · Shiley, Inc. · Dec 1984
UNIVERSAL LEVEL SENSOR
K831879 · 3M Health Care, Sarns · Jul 1983
GAMBRO BLOOD LEVEL DETECTOR LCS 10
K822821 · Gambro, Inc. · Oct 1982