510(k) · Cleared
ClearedLifenet System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Physio-Control, Inc. · MSX System, Network And Communication, Physiological Monitors
Cleared on Nov 5, 2010 as substantially equivalent to K093925 (Physio-Control, Inc., 2010) after a 43-day review. Its family tree reaches back 4 generations to 1997. 7 later devices descend from it.
- Decided
- Nov 5, 2010
- Review
- 43 days
- Class
- Class II
- Product code
- MSX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K971723 (1997). 5 ancestors in all. 7 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK971723 Fastak Suture Anchor (11.7MM)/(7.5MM)Arthrex, Inc. · 1997
- 3 generations backK051219 PushlockArthrex, Inc. · 2005
- 2 generations backK073509 Twinfix PK FP Suture AnchorSmith & Nephew, Inc. · 2008
- 1 generation backK093925 Lifenet SystemPhysio-Control, Inc. · 2010
- This deviceK102757 Lifenet SystemPhysio-Control, Inc. · 2010
- Descendant · cites it directly · 5 of its ownK111296 Zoll RescuenetlinkZoll Medical Corporation, World Wide Headquarters · 2011
- Descendant · 2 generations on · 2 of its ownK141774 Zoll X SeriesZOLL Medical Corporation · 2014
- Descendant · 3 generations on · 1 of its ownK202375 ZOLL Propaq MZOLL Medical Corporation · 2021
- Descendant · 2 generations on · 1 of its ownK133484 Zoll X SeriesZoll Medical Corp · 2014
- Descendant · 4 generations on · 0 of its ownK233354 WVSM Pro (Series) (500-0030-XX)Athena Gtx, Inc. · 2024
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K111296Zoll RescuenetlinkZoll Medical Corporation, World Wide Headquarters · 2011 · cites it directly5descendants
- K141774Zoll X SeriesZOLL Medical Corporation · 2014 · 2 generations on2descendants
- K202375ZOLL Propaq MZOLL Medical Corporation · 2021 · 3 generations on1descendant
- K133484Zoll X SeriesZoll Medical Corp · 2014 · 2 generations on1descendant
- K233354WVSM Pro (Series) (500-0030-XX)Athena Gtx, Inc. · 2024 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K971723 | Fastak Suture Anchor (11.7MM)/(7.5MM) | Arthrex, Inc. | 1997 | — |
| −3 | K051219 | Pushlock | Arthrex, Inc. | 2005 | — |
| −2 | K073509 | Twinfix PK FP Suture Anchor | Smith & Nephew, Inc. | 2008 | — |
| −1 | K093925 | Lifenet System | Physio-Control, Inc. | 2010 | — |
| 0 (this device) | K102757 | Lifenet System | Physio-Control, Inc. | 2010 | — |
| +1 | K111296 | Zoll Rescuenetlink | Zoll Medical Corporation, World Wide Headquarters | 2011 | — |
| +2 | K141774 | Zoll X Series | ZOLL Medical Corporation | 2014 | — |
| +3 | K202375 | ZOLL Propaq M | ZOLL Medical Corporation | 2021 | — |
| +2 | K133484 | Zoll X Series | Zoll Medical Corp | 2014 | — |
| +4 | K233354 | WVSM Pro (Series) (500-0030-XX) | Athena Gtx, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 3 | 0 |
| 2021 | 1 | 0 |
| 2024 | 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 MSX? 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 MSX device
- #1 K242750 Central Stationscore 21.5 · 31 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 |
|---|---|---|---|
| * | K093925 | Lifenet SystemSummary page 1…duct Code: MSX Classification Panel: Cardiovascular Device Regulation Number: 21 CFR 870.2300 Identification of L.IFENET System (K093925) the Legally Classification name: Cardiac monitor (including cardiotachometer and rate alarm) Marketed Device Device class… | 2010 |
What descends from it? (7)
2 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?
- The line of descent spans 13 years and passes through 3 companies; a new generation was cleared every 2.7 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K111296 (Zoll Medical Corporation, World Wide Headquarters, 2011) has gone furthest, with 5 descendants of its own.
How does its category compare?
All MSX devicesMSX System, Network And Communication, Physiological Monitors: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · MSX
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MSX
295in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MSX
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MSX
19in 2025
MAUDE reports naming product code MSX, 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 | 4 | 58 | 1 | 5 |
| 2008 | 1 | — | 1 | 6 |
| 2009 | 1 | — | 2 | 7 |
| 2010 | 3 | 43 | 1 | 14 |
| 2011 | 7 | 72 | 1 | 3 |
| 2012 | 4 | 145 | 2 | 4 |
| 2013 | 2 | — | 0 | 17 |
| 2014 | 3 | 165 | 0 | 32 |
| 2015 | 5 | 138 | 2 | 31 |
| 2016 | 3 | 174 | 0 | 11 |
| 2017 | 2 | — | 2 | 16 |
| 2018 | 4 | 111 | 1 | 15 |
| 2019 | 4 | 92 | 0 | 15 |
| 2020 | 5 | 193 | 0 | 25 |
| 2021 | 3 | 227 | 0 | 17 |
| 2022 | 5 | 177 | 1 | 18 |
| 2023 | 3 | 244 | 0 | 10 |
| 2024 | 4 | 212 | 0 | 32 |
| 2025 | 4 | 295 | 1 | 19 |
| 2026 | 5 | 145 | 2 | — |
What is it indicated for?
The LIFENET System is an optional data transmission system that provides the capability to transmit real time 12-Lead ECG reports and other physiological data to a receiving destination at a remote location. Data received from the field can be used for diagnosis, disposition, and therapy decisions by qualified medical personnel.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102757 · printed Nov 4, 2026
Cite this page
510(k) Report. “K102757: Lifenet System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K102757
Report an extraction error
Are you the manufacturer?
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