Cleared Traditional

K852407 - SENSOR TAPE CAT. NO. ST-45

K852407 is an FDA 510(k) clearance for SENSOR TAPE CAT. NO. ST-45, manufactured by American Omni Medical, Inc.. The device is a Class 2 Cardiovascular device with 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

FDA 510(k) Submission Details - K852407

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
Combination Product No
PCCP Authorized No
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.

DTW Device Classification - Class 2, Special Controls

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 11
Devices cleared under the same product code (DTW) and FDA review panel - the closest regulatory comparables to K852407.
SARNS 9000 PERFUSION SYSTEM W/ALERT ONLY LEVEL
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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