Cleared Traditional

K822091 - SIEMENS SIRECUST SYSTEM

K822091 · Analogic Corp. · Cardiovascular device
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Oct 1982
Decision
95d
Days
-
Risk

K822091 is an FDA 510(k) clearance for the SIEMENS SIRECUST SYSTEM.

Submitted by Analogic Corp. (Mchenry, US). The FDA issued a Cleared decision on October 18, 1982 after a review of 95 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel. 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 Analogic Corp. devices

FDA 510(k) Submission Details - K822091

510(k) Number K822091 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 1982
Decision Date October 18, 1982
Days to Decision 95 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
30d faster than avg
Panel avg: 125d · This submission: 95d
Pathway characteristics
Predicate-based equivalence.

Device Classification - Class ,

Product Code -
Device Class -