Cleared Traditional

K831879 - UNIVERSAL LEVEL SENSOR

K831879 is the FDA 510(k) clearance for UNIVERSAL LEVEL SENSOR by 3M Health Care, Sarns. It is a Class 2 Cardiovascular device (product code DTW) cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K831879 · 3M Health Care, Sarns · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1983
Decision
43d
Days
Class 2
Risk

K831879 is an FDA 510(k) clearance for the UNIVERSAL LEVEL SENSOR. Classified as Monitor And/or Control, Level Sensing, Cardiopulmonary Bypass (product code DTW), Class II - Special Controls.

Submitted by 3M Health Care, Sarns (Mchenry, US). The FDA issued a Cleared decision on July 26, 1983 after a review of 43 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 3M Health Care, Sarns devices

Submission Details

510(k) Number K831879 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 13, 1983
Decision Date July 26, 1983
Days to Decision 43 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
82d faster than avg
Panel avg: 125d · This submission: 43d
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 8
Devices cleared under the same product code (DTW) and FDA review panel - the closest regulatory comparables to K831879.
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
GAMBRO BLOOD LEVEL DETECTOR LCS 10
K822821 · Gambro, Inc. · Oct 1982
MONITOR KITS, BLOOD LEVEL
K781145 · 3M Health Care, Sarns · Jul 1978