Cleared Special

K021681 - MICROPAQ, MODELS 402, 404

K021681 is an FDA 510(k) clearance for MICROPAQ, manufactured by Welch Allyn Protocol, Inc.. The device is a Class 2 Cardiovascular device with product code DRT cleared through the Special 510(k) pathway after a 62-day FDA review.

K021681 · Welch Allyn Protocol, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2002
Decision
62d
Days
Class 2
Risk

K021681 is an FDA 510(k) clearance for the MICROPAQ, MODELS 402, 404. Classified as Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) (product code DRT), Class II - Special Controls.

Submitted by Welch Allyn Protocol, Inc. (Beaverton, US). The FDA issued a Cleared decision on July 23, 2002 after a review of 62 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2300 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K021681

510(k) Number K021681 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 2002
Decision Date July 23, 2002
Days to Decision 62 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 125d · This submission: 62d
Pathway characteristics
Modification to existing cleared device.

DRT Device Classification - Class 2, Special Controls

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 273
Devices cleared under the same product code (DRT) and FDA review panel - the closest regulatory comparables to K021681.
ENVAN HEART RATE MONITOR
K030656 · Envan, LLC · Apr 2003
PHYSIOLOGICAL MONITOR, MODEL 3000 (SERIES)
K023616 · Ivy Biomedical Systems, Inc. · Nov 2002
507EL VITAL SIGNS MONITOR
K022435 · Criticare Systems, Inc. · Aug 2002
SIEMENS INFINITY SC 6002XL MODIFICATIONS
K020144 · Siemens Medical Solutions USA, Inc. · Feb 2002
SORIN BIOMEDICA SMART BCD VANGUARD,SURFACE MODIFIED BLOOD CARDIOPLEGIA SYSTEM
K012763 · Cobe Cardiovascular, Inc. · Nov 2001
PROPAQ ENCORE MODELS 202, 204, 206
K012451 · Welch Allyn Protocol, Inc. · Aug 2001
K021681 · MICROPAQ, MODELS 402, 404
Download PDF FDA Summary Welch Allyn Protocol,…