Cleared Traditional

K822873 - DEVETHERM

K822873 is an FDA 510(k) clearance for DEVETHERM, manufactured by Eko Scann AB. The device is a Class 2 Cardiovascular device with product code DQB cleared through the Traditional 510(k) pathway after a 178-day FDA review.

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

FDA 510(k) Submission Details - K822873

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.

DQB Device Classification - Class 2, Special Controls

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.