510(k) · Cleared
ClearedMedlog, Model 1-0-10
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bmc Gesellschaft Fur Medizintechnik Mbh · MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Cleared on Oct 30, 2006 as substantially equivalent to K032142 (Capsule Technologie, 2003) after a 223-day review. Its family tree reaches back 4 generations to 2000.
- Decided
- Oct 30, 2006
- Review
- 223 days
- Class
- Class II
- Product code
- MWI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K000635 (2000). No later device cites it as a predicate yet.
- Root · 4 generations backK000635 Modification to HP M2376A Device Link SystemAgilent Technologies, Inc. · 2000
- 3 generations backK013019 DatacaptorCapsule Technologie · 2001 · Recalled
- 2 generations backK020197 Modification to DatacaptorCapsule Technologie · 2002 · Recalled
- 1 generation backK032142 DatacaptorCapsule Technologie · 2003 · Recalled
- This deviceK060756 Medlog, Model 1-0-10Bmc Gesellschaft Fur Medizintechnik Mbh · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K000635 | Modification to HP M2376A Device Link System | Agilent Technologies, Inc. | 2000 | — |
| −3 | K013019 | Datacaptor | Capsule Technologie | 2001 | 2 |
| −2 | K020197 | Modification to Datacaptor | Capsule Technologie | 2002 | 2 |
| −1 | K032142 | Datacaptor | Capsule Technologie | 2003 | 2 |
| 0 (this device) | K060756 | Medlog, Model 1-0-10 | Bmc Gesellschaft Fur Medizintechnik Mbh | 2006 | — |
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 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? (1)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K032142 | DatacaptorSummary page 1…me: Data Collection Software 2. Equivalent legally marketed device This product is similar in design and identical in funtion to the DataCaptor Software, K032142. The premarket notfication adds compatibility with basic capabilities of DataCaptor. 3. Indications of Use (intended Use) The M… | 2003 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 6 years and passes through 3 companies; a new generation was cleared every 1.7 years on median.
- 3 of the 4 ancestors have a recall of any class.
- 4 other devices also cite its predicate K032142.
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 | — |
What is it indicated for?
The MEDLOG System is indicated for the use in data collection and clinical information management. MEDLOG is connected with independent bedside or clinical devices either directly of through networks.
The MEDLOG is not intended for monitoring purposes, nor is the software intended to control any of the clinical devices, which is connected to.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060756 · printed Nov 4, 2026
Cite this page
510(k) Report. “K060756: Medlog, Model 1-0-10.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060756
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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