Cleared Traditional

K822821 - GAMBRO BLOOD LEVEL DETECTOR LCS 10

K822821 is an FDA 510(k) clearance for GAMBRO BLOOD LEVEL DETECTOR LCS 10, manufactured by Gambro, Inc.. The device is a Class 2 Cardiovascular device with product code DTW cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K822821 · Gambro, Inc. · Cardiovascular device
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Oct 1982
Decision
28d
Days
Class 2
Risk

K822821 is an FDA 510(k) clearance for the GAMBRO BLOOD LEVEL DETECTOR LCS 10. Classified as Monitor And/or Control, Level Sensing, Cardiopulmonary Bypass (product code DTW), Class II - Special Controls.

Submitted by Gambro, Inc. (Walker, US). The FDA issued a Cleared decision on October 18, 1982 after a review of 28 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 Gambro, Inc. devices

FDA 510(k) Submission Details - K822821

510(k) Number K822821 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 1982
Decision Date October 18, 1982
Days to Decision 28 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
97d faster than avg
Panel avg: 125d · This submission: 28d
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 9
Devices cleared under the same product code (DTW) and FDA review panel - the closest regulatory comparables to K822821.
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
MONITOR KITS, BLOOD LEVEL
K781145 · 3M Health Care, Sarns · Jul 1978