510(k) · Cleared
ClearedPhysioglove ES
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Commwell, Ltd. · DPS Electrocardiograph
Cleared on Apr 25, 2006 as substantially equivalent to K030535 (Qrs Diagnostic, LLC, 2003) after a 406-day review. Its family tree reaches back 2 generations to 1998. 2 later devices descend from it.
- Decided
- Apr 25, 2006
- Review
- 406 days
- Class
- Class II
- Product code
- DPS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K974351 (1998). 3 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK974351 Biolog 3000 ElectrocardiographMicromedical, Inc. · 1998
- 1 generation backK030535 Ekgcard SystemQrs Diagnostic, LLC · 2003
- This deviceK050674 Physioglove ESCommwell, Ltd. · 2006
- Descendant · cites it directly · 1 of its ownK103791 Physioglove ES with Ecg AnalysisCommwell, Ltd. · 2011
- Descendant · 2 generations on · 0 of its ownK133703 Physioglove ET SystemCommwell R&D, Ltd. · 2014
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K974351 | Biolog 3000 Electrocardiograph | Micromedical, Inc. | 1998 | — |
| −1 | K030535 | Ekgcard System | Qrs Diagnostic, LLC | 2003 | — |
| 0 (this device) | K050674 | Physioglove ES | Commwell, Ltd. | 2006 | — |
| +1 | K103791 | Physioglove ES with Ecg Analysis | Commwell, Ltd. | 2011 | — |
| +2 | K133703 | Physioglove ET System | Commwell R&D, Ltd. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2014 | 1 | 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 DPS? 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 DPS device
- #1 K212112 Cardiologs Holter Platformscore 18.6 · 5 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 |
|---|---|---|---|
| * | K030535 | Ekgcard SystemSummary page 2…Substantial Equivalence The PhysioGlove ES Model I has a substantially similar intended use and indications for use as the QRS Diagnostic's EKGCard (K030535), and uses substantially similar technology. None of the minor differences between the devices raise new ques… | 2003 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K103791 | Physioglove ES with Ecg Analysis | 2011 | 1 |
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 8 years and passes through 3 companies; a new generation was cleared every 5.2 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K103791 (Commwell, Ltd., 2011) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K030535.
How does its category compare?
All DPS devicesDPS Electrocardiograph: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DPS
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DPS
163in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DPS
3in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · DPS
55in 2025
MAUDE reports naming product code DPS, 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 | 11 | 87 | 2 | 9 |
| 2008 | 13 | 31 | 0 | 17 |
| 2009 | 14 | 84 | 1 | 14 |
| 2010 | 11 | 104 | 2 | 21 |
| 2011 | 22 | 154 | 1 | 121 |
| 2012 | 12 | 117 | 0 | 56 |
| 2013 | 10 | 134 | 0 | 15 |
| 2014 | 11 | 253 | 0 | 15 |
| 2015 | 8 | 178 | 0 | 30 |
| 2016 | 11 | 229 | 0 | 12 |
| 2017 | 9 | 177 | 0 | 15 |
| 2018 | 14 | 221 | 0 | 19 |
| 2019 | 3 | 178 | 9 | 27 |
| 2020 | 6 | 224 | 2 | 59 |
| 2021 | 5 | 135 | 1 | 24 |
| 2022 | 6 | 244 | 1 | 59 |
| 2023 | 10 | 236 | 3 | 54 |
| 2024 | 8 | 260 | 4 (1) | 64 |
| 2025 | 6 | 163 | 3 | 55 |
| 2026 | 6 | 258 | 4 | — |
What is it indicated for?
The PhysioGlove ES Model I is a reusable 12-Lead diagnostic ECG examination system. It is intended for use in resting diagnostic electrocardiograph examination of adults. It is intended for use in physician offices, hospitals, outpatient clinics, or similar settings by or on the order of a physician or similarly qualified healthcare professional. The device only provides waveform parameters for healthcare provider interpretation and does not itself provide suggested interpretations.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050674 · printed Nov 3, 2026
Cite this page
510(k) Report. “K050674: Physioglove ES.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K050674
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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