510(k) · Cleared
ClearedSavi Wireless, Model PM500
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medicomp, Inc. · DRG Transmitters And Receivers, Physiological Signal, Radiofrequency
Cleared on Oct 26, 2009 as substantially equivalent to K043454 (Medicomp, Inc., 2005) after a 138-day review. Its family tree reaches back 2 generations to 1998. 1 later device descends from it.
- Decided
- Oct 26, 2009
- Review
- 138 days
- Class
- Class II
- Product code
- DRG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K981119 (1998). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK981119 Cardiopal Model Number PM20Medicomp, Inc. · 1998
- 1 generation backK043454 Cardiopal AI with Diogenes SV (Cardiopal SV), Model PM410Medicomp, Inc. · 2005
- This deviceK091696 Savi Wireless, Model PM500Medicomp, Inc. · 2009
- Descendant · cites it directly · 0 of its ownK161916 TelePatch Cardiac MonitorMedicomp, Inc. · 2016
Most influential descendants
Showing 1 of 1 · See all- K161916TelePatch Cardiac MonitorMedicomp, Inc. · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K981119 | Cardiopal Model Number PM20 | Medicomp, Inc. | 1998 | — |
| −1 | K043454 | Cardiopal AI with Diogenes SV (Cardiopal SV), Model PM410 | Medicomp, Inc. | 2005 | — |
| 0 (this device) | K091696 | Savi Wireless, Model PM500 | Medicomp, Inc. | 2009 | — |
| +1 | K161916 | TelePatch Cardiac Monitor | Medicomp, Inc. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 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 DRG? 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 DRG device
- #1 K223711 ANNE Onescore 20.8 · 11 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 |
|---|---|---|---|
| * | K043454 | Cardiopal AI with Diogenes SV (Cardiopal SV), Model PM410Summary page 1…y Prepared: May 8, 2009 Contact: Mr. Michael Thomas 2. Name of the Device: SAVI Wireless Model PM500 3. Predicate Device Information: K#043454, CardioPAL SAVI (Model PM410) Event/Loop Recorder, Medicomp, Inc. 4. Device Description: The SAVI Wireless Mod… | 2005 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K161916 | TelePatch Cardiac Monitor | 2016 | 0 |
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 11 years and passes through 1 company; a new generation was cleared every 6.4 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K161916 (Medicomp, Inc., 2016) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K043454.
How does its category compare?
All DRG devicesDRG Transmitters And Receivers, Physiological Signal, Radiofrequency: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · DRG
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DRG
127in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DRG
3in 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DRG
52in 2025
MAUDE reports naming product code DRG, 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 | 6 | 63 | 3 | 14 |
| 2008 | 5 | 74 | 0 | 9 |
| 2009 | 13 | 94 | 0 | 5 |
| 2010 | 10 | 68 | 0 | 13 |
| 2011 | 9 | 104 | 0 | 12 |
| 2012 | 12 | 103 | 0 | 9 |
| 2013 | 13 | 146 | 0 | 13 |
| 2014 | 10 | 177 | 0 | 97 |
| 2015 | 2 | — | 0 | 131 |
| 2016 | 2 | — | 0 | 182 |
| 2017 | 7 | 98 | 0 | 484 |
| 2018 | 6 | 220 | 0 | 166 |
| 2019 | 5 | 122 | 0 | 70 |
| 2020 | 6 | 159 | 0 | 82 |
| 2021 | 2 | — | 0 | 107 |
| 2022 | 6 | 287 | 0 | 43 |
| 2023 | 4 | 212 | 0 | 19 |
| 2024 | 3 | 125 | 0 | 26 |
| 2025 | 3 | 127 | 0 | 52 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
The SAVI Wireless PM500, is a pager-sized, handheld or patient worn device designed specifically to record and transmit ambulatory ECG signals. The device can be worn for days or weeks, as it is intended for use by patients who are experiencing symptoms that are transient and infrequent in nature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091696 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091696: Savi Wireless, Model PM500.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091696
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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