Cleared Traditional

K921930 - SIEMENS SIRECUST 700 BEDSIDES/ACCESSORIES

K921930 is the FDA 510(k) clearance for SIEMENS SIRECUST 700 BEDSIDES/ACCESSORIES by Siemens Medical Electronics. It is a Class 2 Cardiovascular device (product code DPS) cleared through the Traditional 510(k) pathway after a 378-day FDA review.

K921930 · Siemens Medical Electronics · Cardiovascular device
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May 1993
Decision
378d
Days
Class 2
Risk

K921930 is an FDA 510(k) clearance for the SIEMENS SIRECUST 700 BEDSIDES/ACCESSORIES, MODIFI. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Siemens Medical Electronics (Danvers, US). The FDA issued a Cleared decision on May 7, 1993 after a review of 378 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2340 - 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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K921930 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 1992
Decision Date May 07, 1993
Days to Decision 378 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
253d slower than avg
Panel avg: 125d · This submission: 378d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DPS Electrocardiograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2340
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 - DPS Electrocardiograph

All 168
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