510(k) · Cleared
ClearedMicropaq, Models 402, 404
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Welch Allyn Protocol, Inc. · DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
Cleared on Jul 23, 2002 as substantially equivalent to K002725 (Protocol Systems, Inc., 2000) after a 62-day review. Its family tree reaches back 1 generation to 2000. 113 later devices descend from it.
- Decided
- Jul 23, 2002
- Review
- 62 days
- Class
- Class II
- Product code
- DRT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K002725 (2000). 113 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK002725 Micropaq, Models 402 and 404Protocol Systems, Inc. · 2000
- This deviceK021681 Micropaq, Models 402, 404Welch Allyn Protocol, Inc. · 2002
- Descendant · cites it directly · 108 of its ownK033378 Vital Signs Monitor, Propaq LTWelch Allyn Protocol, Inc. · 2004 · Recalled
- Descendant · 2 generations on · 65 of its ownK121013 Connex Vital Signs Monitor 6000 SeriesWelch Allyn, Inc. · 2012
- Descendant · 3 generations on · 58 of its ownK140188 Masimo Root Monitoring SystemMasimo Corporation · 2014
- Descendant · 4 generations on · 51 of its ownK142394 Masimo Root Monitoring System and AccesoriesMasimo Corporation · 2014
- Descendant · 5 generations on · 24 of its ownK151644 Masimo Root Vital Signs Monitoring System and AccessoriesMasimo Corporation · 2016
Showing 5 of 113 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 113 · See all- K033378Vital Signs Monitor, Propaq LTWelch Allyn Protocol, Inc. · 2004 · cites it directly108descendants
- K121013Connex Vital Signs Monitor 6000 SeriesWelch Allyn, Inc. · 2012 · 2 generations on65descendants
- K140188Masimo Root Monitoring SystemMasimo Corporation · 2014 · 3 generations on58descendants
- K142394Masimo Root Monitoring System and AccesoriesMasimo Corporation · 2014 · 4 generations on51descendants
- K151644Masimo Root Vital Signs Monitoring System and AccessoriesMasimo Corporation · 2016 · 5 generations on24descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K002725 | Micropaq, Models 402 and 404 | Protocol Systems, Inc. | 2000 | — |
| 0 (this device) | K021681 | Micropaq, Models 402, 404 | Welch Allyn Protocol, Inc. | 2002 | — |
| +1 | K033378 | Vital Signs Monitor, Propaq LT | Welch Allyn Protocol, Inc. | 2004 | 3 |
| +2 | K121013 | Connex Vital Signs Monitor 6000 Series | Welch Allyn, Inc. | 2012 | — |
| +3 | K140188 | Masimo Root Monitoring System | Masimo Corporation | 2014 | — |
| +4 | K142394 | Masimo Root Monitoring System and Accesories | Masimo Corporation | 2014 | — |
| +5 | K151644 | Masimo Root Vital Signs Monitoring System and Accessories | Masimo Corporation | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 3 | 0 |
| 2014 | 5 | 0 |
| 2015 | 8 | 0 |
| 2016 | 5 | 0 |
| 2017 | 4 | 0 |
| 2018 | 8 | 0 |
| 2019 | 9 | 0 |
| 2020 | 7 | 0 |
| 2021 | 3 | 0 |
| 2022 | 11 | 0 |
| 2023 | 9 | 0 |
| 2024 | 11 | 0 |
| 2025 | 13 | 0 |
| 2026 | 8 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DRT? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DRT device
- #1 K252676 The Circadia C300 System (C300)score 15.3 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K002725 | Micropaq, Models 402 and 404Summary page 2…he Predicate Device The Micropaq 400 series monitors are substantially equivalent to the Micropaq 400 series monitors cleared for market under 5 1O(k) submission number K002725. The Sp02 channel in the model 404 is substantially equivalent to the S p 0 2 channel in the Nellcor Puritan Bennett, 1nc.N-595 P… | 2000 |
| 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…eir Vital ViewTM 2.4 Central Station, and the S p 0 2 channel in the Nellcor Puritan Bennett, Inc. N-595 Pulse Oximeter cleared for market under 510(k) submission number K019821. This 510(k) Summary of Safety and Effectiveness may be copied and submitted to interested parties as required by 21CFR807.92.… | |
| * | — | Criticare System, Inc. MPT 2.4 Multiple Parameter Telemetry and RF link to their Vital… Named without a submission number |
What descends from it? (113)
See all 1133 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All DRT devicesDRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DRT
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DRT
228in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DRT
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DRT
40in 2025
MAUDE reports naming product code DRT, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 113 |
| 2008 | 1 | — | 0 | 99 |
| 2009 | 6 | 70 | 0 | 118 |
| 2010 | 3 | 44 | 0 | 63 |
| 2011 | 3 | 149 | 1 | 36 |
| 2012 | 1 | — | 0 | 47 |
| 2013 | 1 | — | 0 | 16 |
| 2014 | 0 | — | 0 | 26 |
| 2015 | 1 | — | 0 | 48 |
| 2016 | 1 | — | 0 | 55 |
| 2017 | 1 | — | 0 | 159 |
| 2018 | 1 | — | 0 | 224 |
| 2019 | 1 | — | 0 | 447 |
| 2020 | 0 | — | 0 | 50 |
| 2021 | 2 | — | 1 | 85 |
| 2022 | 1 | — | 0 | 35 |
| 2023 | 1 | — | 0 | 47 |
| 2024 | 3 | 228 | 1 | 29 |
| 2025 | 1 | — | 0 | 40 |
| 2026 | 5 | 120 | 0 | — |
What is it indicated for?
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…
Read the full statement (182 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021681 · printed Nov 6, 2026
Cite this page
510(k) Report. “K021681: Micropaq, Models 402, 404.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K021681
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026