Cleared Traditional

DEVETHERM (K822873) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K822873 · Eko Scann AB · Cardiovascular device
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Mar 1983
Decision
178d
Days
Class 2
Risk

K822873 is an FDA 510(k) clearance for the DEVETHERM. Classified as Phlebograph, Impedance (product code DQB), Class II - Special Controls.

Submitted by Eko Scann AB (Mchenry, US). The FDA issued a Cleared decision on March 24, 1983 after a review of 178 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2750 - 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 Eko Scann AB devices

Submission Details

510(k) Number K822873 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 1982
Decision Date March 24, 1983
Days to Decision 178 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
53d slower than avg
Panel avg: 125d · This submission: 178d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DQB Phlebograph, Impedance
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2750
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.