510(k) · Cleared
ClearedZoll Rescuenet 12-Lead
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
ZOLL Medical Corporation · MSX System, Network And Communication, Physiological Monitors
Cleared on Nov 20, 2012 as substantially equivalent to K102757 (Physio-Control, Inc., 2010) after a 147-day review. Its family tree reaches back 5 generations to 1997.
- Decided
- Nov 20, 2012
- Review
- 147 days
- Class
- Class II
- Product code
- MSX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K971723 (1997). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK971723 Fastak Suture Anchor (11.7MM)/(7.5MM)Arthrex, Inc. · 1997
- 4 generations backK051219 PushlockArthrex, Inc. · 2005
- 3 generations backK073509 Twinfix PK FP Suture AnchorSmith & Nephew, Inc. · 2008
- 2 generations backK093925 Lifenet SystemPhysio-Control, Inc. · 2010
- 1 generation backK102757 Lifenet SystemPhysio-Control, Inc. · 2010
- This deviceK121865 Zoll Rescuenet 12-LeadZOLL Medical Corporation · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K971723 | Fastak Suture Anchor (11.7MM)/(7.5MM) | Arthrex, Inc. | 1997 | — |
| −4 | K051219 | Pushlock | Arthrex, Inc. | 2005 | — |
| −3 | K073509 | Twinfix PK FP Suture Anchor | Smith & Nephew, Inc. | 2008 | — |
| −2 | K093925 | Lifenet System | Physio-Control, Inc. | 2010 | — |
| −1 | K102757 | Lifenet System | Physio-Control, Inc. | 2010 | — |
| 0 (this device) | K121865 | Zoll Rescuenet 12-Lead | ZOLL Medical Corporation | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 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 |
|---|---|---|---|
| * | K102757 | Lifenet SystemSummary page 2…nd functions of the proposed RescueNet 12-Lead are substantially equivalent to the corresponding features and functions of the Physio-Control LIFENET System (K1 02757, cleared for use on 11/5/2010). Comparison of Technological Characteristics RescueNet 12-Lead features and functions are si… | 2010 |
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 15 years and passes through 4 companies; a new generation was cleared every 2.0 years on median.
- None of the 6 ancestors has a recall.
- 1 other device also cites its predicate K102757.
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. 2012, 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 RescueNet 12-Lead (RN12L) System is a data transmission and reception system that provides the capability to receive 12-Lead ECG reports, other physiological data, patient demographic, and EMS agency information from authorized monitor/defibrillators and other patient care systems and route it to a receiving destination at a remote location for display on an Internet Browser. Data is received from the field and 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/K121865 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121865: Zoll Rescuenet 12-Lead.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121865
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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