510(k) · Cleared
ClearedModification to HP M2376A Device Link System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Agilent Technologies, Inc. · MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Cleared on Mar 20, 2000 after a 24-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 14 later devices descend from it.
- Decided
- Mar 20, 2000
- Review
- 24 days
- Class
- Class II
- Product code
- MWI
- Recalls
- None
- Predicates
- 0
14 later devices descend from it, 1 citing it directly.
- This deviceK000635 Modification to HP M2376A Device Link SystemAgilent Technologies, Inc. · 2000
- Descendant · cites it directly · 13 of its ownK013019 DatacaptorCapsule Technologie · 2001 · Recalled
- Descendant · 2 generations on · 12 of its ownK020197 Modification to DatacaptorCapsule Technologie · 2002 · Recalled
- Descendant · 2 generations on · 11 of its ownK032142 DatacaptorCapsule Technologie · 2003 · Recalled
- Descendant · 3 generations on · 6 of its ownK040969 Poise DataenginePoise Technology Corporation · 2004
- Descendant · 4 generations on · 5 of its ownK101571 Xper Information Management and Flex Cardio Physiomonitoring SystemsWitt Biomedical Corp · 2010 · Recalled
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K013019DatacaptorCapsule Technologie · 2001 · cites it directly13descendants
- K020197Modification to DatacaptorCapsule Technologie · 2002 · 2 generations on12descendants
- K032142DatacaptorCapsule Technologie · 2003 · 2 generations on11descendants
- K040969Poise DataenginePoise Technology Corporation · 2004 · 3 generations on6descendants
- K101571Xper Information Management and Flex Cardio Physiomonitoring SystemsWitt Biomedical Corp · 2010 · 4 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K000635 | Modification to HP M2376A Device Link System | Agilent Technologies, Inc. | 2000 | — |
| +1 | K013019 | Datacaptor | Capsule Technologie | 2001 | 2 |
| +2 | K020197 | Modification to Datacaptor | Capsule Technologie | 2002 | 2 |
| +2 | K032142 | Datacaptor | Capsule Technologie | 2003 | 2 |
| +3 | K040969 | Poise Dataengine | Poise Technology Corporation | 2004 | — |
| +4 | K101571 | Xper Information Management and Flex Cardio Physiomonitoring Systems | Witt Biomedical Corp | 2010 | 8 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 2 | 0 |
| 2010 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 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 MWI? 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 MWI device
- #1 K230457 Empatica Health Monitoring Platform…score 28.0 · 39 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? (14)
See all 141 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K013019 | Datacaptor | 2001 | 13 |
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, K013019 (Capsule Technologie, 2001) has gone furthest, with 13 descendants of its own.
How does its category compare?
All MWI devicesMWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MWI
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MWI
247in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MWI
9so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MWI
182in 2025
MAUDE reports naming product code MWI, 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 | 9 | 42 | 1 | 3 |
| 2008 | 9 | 49 | 1 | 3 |
| 2009 | 6 | 112 | 2 | 20 |
| 2010 | 17 | 58 | 2 | 17 |
| 2011 | 11 | 78 | 3 | 16 |
| 2012 | 13 | 104 | 5 | 31 |
| 2013 | 20 | 85 | 3 | 42 |
| 2014 | 16 | 148 | 6 | 30 |
| 2015 | 19 | 127 | 1 | 31 |
| 2016 | 12 | 165 | 0 | 51 |
| 2017 | 13 | 205 | 2 | 85 |
| 2018 | 11 | 217 | 0 | 158 |
| 2019 | 14 | 255 | 4 | 169 |
| 2020 | 8 | 138 | 0 | 110 |
| 2021 | 9 | 161 | 0 | 188 |
| 2022 | 5 | 231 | 2 | 168 |
| 2023 | 8 | 250 | 0 | 179 |
| 2024 | 10 | 202 | 5 | 120 |
| 2025 | 4 | 247 | 0 | 182 |
| 2026 | 6 | 239 | 9 | — |
https://510kreport.com/device/K000635 · printed Nov 6, 2026
Cite this page
510(k) Report. “K000635: Modification to HP M2376A Device Link System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K000635
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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