Cleared Traditional

K822098 - BT 794-BLOOD/FLUID WARMER

K822098 is the FDA 510(k) clearance for BT 794-BLOOD/FLUID WARMER by Electromedics, Inc.. It is a Class 2 General Hospital device (product code LGZ) cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K822098 · Electromedics, Inc. · General Hospital
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Aug 1982
Decision
35d
Days
Class 2
Risk

K822098 is an FDA 510(k) clearance for the BT 794-BLOOD/FLUID WARMER. Classified as Warmer, Thermal, Infusion Fluid (product code LGZ), Class II - Special Controls.

Submitted by Electromedics, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 20, 1982 after a review of 35 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5725 - the FDA general hospital device 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 Electromedics, Inc. devices

Submission Details

510(k) Number K822098 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 1982
Decision Date August 20, 1982
Days to Decision 35 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
94d faster than avg
Panel avg: 129d · This submission: 35d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LGZ Warmer, Thermal, Infusion Fluid
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5725
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 General Hospital devices follow this clearance model.