510(k) · Cleared
ClearedWelch Allyn Instrument Interface Module
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Welch Allyn, Inc. · MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Cleared on Jul 13, 2000 after an 85-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 11 later devices descend from it.
- Decided
- Jul 13, 2000
- Review
- 85 days
- Class
- Class II
- Product code
- MWI
- Recalls
- None
- Predicates
- 0
11 later devices descend from it, 3 citing it directly.
- This deviceK001265 Welch Allyn Instrument Interface ModuleWelch Allyn, Inc. · 2000
- Descendant · cites it directly · 7 of its ownK072449 CP100 & 200 12-Lead Resting ElectrocardiographsWelch Allyn, Inc. · 2007
- Descendant · 2 generations on · 4 of its ownK102767 Cardio XPBionet Co., Ltd. · 2011
- Descendant · 3 generations on · 3 of its ownK113306 Cardio 7Bionet Co., Ltd. · 2012
- Descendant · 4 generations on · 2 of its ownK220535 Cardio10Bionet Co., Ltd. · 2022
- Descendant · 2 generations on · 1 of its ownK131573 CP150 ElectrocardiographWelch Allyn, Inc. · 2013
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K072449CP100 & 200 12-Lead Resting ElectrocardiographsWelch Allyn, Inc. · 2007 · cites it directly7descendants
- K102767Cardio XPBionet Co., Ltd. · 2011 · 2 generations on4descendants
- K113306Cardio 7Bionet Co., Ltd. · 2012 · 3 generations on3descendants
- K220535Cardio10Bionet Co., Ltd. · 2022 · 4 generations on2descendants
- K131573CP150 ElectrocardiographWelch Allyn, Inc. · 2013 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K001265 | Welch Allyn Instrument Interface Module | Welch Allyn, Inc. | 2000 | — |
| +1 | K072449 | CP100 & 200 12-Lead Resting Electrocardiographs | Welch Allyn, Inc. | 2007 | — |
| +2 | K102767 | Cardio XP | Bionet Co., Ltd. | 2011 | — |
| +3 | K113306 | Cardio 7 | Bionet Co., Ltd. | 2012 | — |
| +4 | K220535 | Cardio10 | Bionet Co., Ltd. | 2022 | — |
| +2 | K131573 | CP150 Electrocardiograph | Welch Allyn, Inc. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 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? (11)
See all 113 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, K072449 (Welch Allyn, Inc., 2007) has gone furthest, with 7 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/K001265 · printed Nov 6, 2026
Cite this page
510(k) Report. “K001265: Welch Allyn Instrument Interface Module.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K001265
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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