Cleared Traditional

K830028 - SIRECUST 456

K830028 is the FDA 510(k) clearance for SIRECUST 456 by Analogic Corp.. It is a Class 2 Cardiovascular device (product code DXH) cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K830028 · Analogic Corp. · Cardiovascular device
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Jan 1983
Decision
17d
Days
Class 2
Risk

K830028 is an FDA 510(k) clearance for the SIRECUST 456. Classified as Transmitters And Receivers, Electrocardiograph, Telephone (product code DXH), Class II - Special Controls.

Submitted by Analogic Corp. (Mchenry, US). The FDA issued a Cleared decision on January 21, 1983 after a review of 17 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2920 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Analogic Corp. devices

Submission Details

510(k) Number K830028 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 04, 1983
Decision Date January 21, 1983
Days to Decision 17 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
108d faster than avg
Panel avg: 125d · This submission: 17d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DXH Transmitters And Receivers, Electrocardiograph, Telephone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2920
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 - DXH Transmitters And Receivers, Electrocardiograph, Telephone

All 109
Devices cleared under the same product code (DXH) and FDA review panel - the closest regulatory comparables to K830028.
INSTANT REPLAY
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K822955 · Medtronic Vascular · Nov 1982
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K821726 · Intermedics, Inc. · Jul 1982
MODEL 535-03 TRACE A PACE
K812755 · Intermedics, Inc. · Nov 1981