Cleared Traditional

K002061 - A&D MEDICAL TM-2550/TM-2551/TM-2560 VIT...

K002061 is the FDA 510(k) clearance for A&D MEDICAL TM-2550/TM-2551/TM-2560 VIT... by A&D Engineering, Inc.. It is a Class 2 Cardiovascular device (product code DRT) cleared through the Traditional 510(k) pathway after a 197-day FDA review.

K002061 · A&D Engineering, Inc. · Cardiovascular device
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Jan 2001
Decision
197d
Days
Class 2
Risk

K002061 is an FDA 510(k) clearance for the A&D MEDICAL TM-2550/TM-2551/TM-2560 VITAL SENSOR MONITOR. Classified as Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) (product code DRT), Class II - Special Controls.

Submitted by A&D Engineering, Inc. (Milpitas, US). The FDA issued a Cleared decision on January 19, 2001 after a review of 197 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2300 - 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 A&D Engineering, Inc. devices

Submission Details

510(k) Number K002061 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 2000
Decision Date January 19, 2001
Days to Decision 197 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
72d slower than avg
Panel avg: 125d · This submission: 197d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DRT Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2300
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 - DRT Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm)

All 143
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