Cleared Traditional

SEISMOCARDIOGRAPH - SCG(TM) 1000 SERIES (K892323) - FDA 510(k) Clearance

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

K892323 · Seismed Instruments, Inc. · Cardiovascular device
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Oct 1989
Decision
207d
Days
Class 2
Risk

K892323 is an FDA 510(k) clearance for the SEISMOCARDIOGRAPH - SCG(TM) 1000 SERIES. Classified as Plethysmograph, Impedance (product code DSB), Class II - Special Controls.

Submitted by Seismed Instruments, Inc. (Minneapolis, US). The FDA issued a Cleared decision on October 30, 1989 after a review of 207 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2770 - 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 Seismed Instruments, Inc. devices

Submission Details

510(k) Number K892323 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 1989
Decision Date October 30, 1989
Days to Decision 207 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
82d slower than avg
Panel avg: 125d · This submission: 207d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DSB Plethysmograph, Impedance
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2770
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.