Cleared Traditional

K002310 - CARDIOBEEPER CB12/12

K002310 is the FDA 510(k) clearance for CARDIOBEEPER CB12/12 by Meridian Medical Technologies , Ltd.. It is a Class 2 Cardiovascular device (product code DXH) cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K002310 · Meridian Medical Technologies , Ltd. · Cardiovascular device
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Oct 2000
Decision
86d
Days
Class 2
Risk

K002310 is an FDA 510(k) clearance for the CARDIOBEEPER CB12/12, MODEL CB12/12. Classified as Transmitters And Receivers, Electrocardiograph, Telephone (product code DXH), Class II - Special Controls.

Submitted by Meridian Medical Technologies , Ltd. (Belfast, IE). The FDA issued a Cleared decision on October 25, 2000 after a review of 86 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 Meridian Medical Technologies , Ltd. devices

Submission Details

510(k) Number K002310 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 2000
Decision Date October 25, 2000
Days to Decision 86 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 125d · This submission: 86d
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 93
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