# K021681: Micropaq, Models 402, 404

- Pathway: 510(k) (Special)
- Applicant: Welch Allyn Protocol, Inc.
- Decided: Jul 23, 2002 after 62 days
- Product code: DRT (Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm))
- Device class: 2
- Regulation: 21 CFR 870.2300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K002725 (2000). 1 ancestor in all.
113 later devices descend from it; 3 cite it directly.
0 of 115 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002725: Micropaq, Models 402 and 404, Protocol Systems, Inc. (2000) Summary page 2.
- (no number) Criticare System, Inc. MPT 2.4 Multiple Parameter Telemetry and RF link to their Vital View 2.4 Central Station: named in the summary without a submission number

## Cited in the summary but kept off the family tree
- K019821: Nellcor Puritan Bennett, Inc. N-595 Pulse Oximeter. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 2.

## Most influential descendants
- K033378: Vital Signs Monitor, Propaq LT (2004), 108 descendants of its own
- K121013: Connex Vital Signs Monitor 6000 Series (2012), 65 descendants of its own
- K140188: Masimo Root Monitoring System (2014), 58 descendants of its own
- K142394: Masimo Root Monitoring System and Accesories (2014), 51 descendants of its own
- K151644: Masimo Root Vital Signs Monitoring System and Accessories (2016), 24 descendants of its own

## Indications for use
The Micropaq monitor is intended to be used by clinicians for single or multiparameter vital signs monitoring of ambulatory and non-ambulatory pediatric and adult patients in health care facilities. It is also intended for patient transport. Micropaq is intended to operate with an Acuity@ central station through wireless communication over Welch Allyn Protocol's FlexNetTM network. FlexNet connects multiple devices through hardwired Ethernet networks and Wireless Local Area Networks (WLANs) to an Acuity@ central station. If the Micropaq is moved out of range or loses communication with the FlexNet network, it continues to monitor the patient, display patient data, and generate local patient alarms or alert messages. The ECG channel is intended for five-lead ECG monitoring. The Pulse Oximetry channel is intended for continuous noninvasive monitoring of functional oxygen saturation of arteriolar hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor). The most likely locations for patients monitored by this device are step-down units, telemetry departments, general med/surg floors, emergency departments, and in-hospital transport. This device is available for sale only upon the order of a physician or licensed health care professional.

Source page: https://510kreport.com/device/K021681
Methodology: https://510kreport.com/methodology