Cleared Traditional

K823712 - BEL BLOOD LEVEL DETECTOR

K823712 is the FDA 510(k) clearance for BEL BLOOD LEVEL DETECTOR by R. Scott Bell. It is a Class 2 Cardiovascular device (product code DTW) cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K823712 · R. Scott Bell · Cardiovascular device
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Feb 1983
Decision
59d
Days
Class 2
Risk

K823712 is an FDA 510(k) clearance for the BEL BLOOD LEVEL DETECTOR. Classified as Monitor And/or Control, Level Sensing, Cardiopulmonary Bypass (product code DTW), Class II - Special Controls.

Submitted by R. Scott Bell (Mchenry, US). The FDA issued a Cleared decision on February 7, 1983 after a review of 59 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all R. Scott Bell devices

Submission Details

510(k) Number K823712 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 1982
Decision Date February 07, 1983
Days to Decision 59 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 125d · This submission: 59d
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 K823712.
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
MONITOR KITS, BLOOD LEVEL
K781145 · 3M Health Care, Sarns · Jul 1978