510(k) · Cleared
ClearedMicropaq, Models 402 and 404
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Protocol Systems, Inc. · DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
Cleared on Nov 21, 2000 after an 82-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 127 later devices descend from it.
- Decided
- Nov 21, 2000
- Review
- 82 days
- Class
- Class II
- Product code
- DRT
- Recalls
- None
- Predicates
- 0
127 later devices descend from it, 4 citing it directly.
- This deviceK002725 Micropaq, Models 402 and 404Protocol Systems, Inc. · 2000
- Descendant · cites it directly · 113 of its ownK021681 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 · cites it directly · 63 of its ownK022453 Modification to Acuity Central Monitoring SystemWelch Allyn Protocol, Inc. · 2002 · Recalled
- Descendant · 3 generations on · 58 of its ownK140188 Masimo Root Monitoring SystemMasimo Corporation · 2014
Showing 5 of 127 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 127 · See all- K021681Micropaq, Models 402, 404Welch Allyn Protocol, Inc. · 2002 · cites it directly113descendants
- K033378Vital Signs Monitor, Propaq LTWelch Allyn Protocol, Inc. · 2004 · cites it directly108descendants
- K121013Connex Vital Signs Monitor 6000 SeriesWelch Allyn, Inc. · 2012 · 2 generations on65descendants
- K022453Modification to Acuity Central Monitoring SystemWelch Allyn Protocol, Inc. · 2002 · cites it directly63descendants
- K140188Masimo Root Monitoring SystemMasimo Corporation · 2014 · 3 generations on58descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K002725 | Micropaq, Models 402 and 404 | Protocol Systems, Inc. | 2000 | — |
| +1 | 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 | — |
| +1 | K022453 | Modification to Acuity Central Monitoring System | Welch Allyn Protocol, Inc. | 2002 | 1 |
| +3 | K140188 | Masimo Root Monitoring System | Masimo Corporation | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 5 | 0 |
| 2013 | 3 | 0 |
| 2014 | 6 | 0 |
| 2015 | 9 | 0 |
| 2016 | 6 | 0 |
| 2017 | 4 | 0 |
| 2018 | 8 | 0 |
| 2019 | 9 | 0 |
| 2020 | 8 | 0 |
| 2021 | 3 | 0 |
| 2022 | 12 | 0 |
| 2023 | 9 | 0 |
| 2024 | 11 | 0 |
| 2025 | 15 | 0 |
| 2026 | 8 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (127)
See all 1274 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?
- Of its descendants, K021681 (Welch Allyn Protocol, Inc., 2002) has gone furthest, with 113 descendants of its own.
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 | — |
https://510kreport.com/device/K002725 · printed Nov 6, 2026
Cite this page
510(k) Report. “K002725: Micropaq, Models 402 and 404.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K002725
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026