510(k) · Cleared
ClearedZoll M Series Ibp Operation; Zoll M Series Temperature Option
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zoll Medical Corp · DSK Computer, Blood-Pressure
Cleared on Jul 31, 2001 after a 47-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 of the 6 devices in its family, counting itself, has a Class I recall. 5 later devices descend from it.
- Decided
- Jul 31, 2001
- Review
- 47 days
- Class
- Class II
- Product code
- DSK
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 1 citing it directly. 1 of the 6 devices in this family, counting this one, has a Class I recall.
- This deviceK011865 Zoll M Series Ibp Operation; Zoll M Series Temperature OptionZoll Medical Corp · 2001
- Descendant · cites it directly · 4 of its ownK061707 Heartstart MRX, Invasive Pressure & Temperature OptionsPhilips Medical Systems · 2006 · Recalled (Class I)
- Descendant · 2 generations on · 2 of its ownK130153 Hearstart MRX with Airway Confimration AssistPhilips Medical Systems · 2013
- Descendant · 3 generations on · 1 of its ownK133659 Heartstart XL+Defibrillator/Monitor with End-Tidal Carbon Dioxide…Philips Medical Systems · 2015
- Descendant · 4 generations on · 0 of its ownK200849 Tempus LS - ManualRemote Diagnostic Technologies, Ltd. A Philips Company · 2020 · Recalled
- Descendant · 2 generations on · 0 of its ownK063375 Heartstart MRX, Models M3535A or M3536APhilips Medical Systems · 2007 · Recalled
Class I recalls in this family
- K061707 Heartstart MRX, Invasive Pressure & Temperature…cites it directly · 2006
Most influential descendants
Showing 5 of 5 · See all- K061707Heartstart MRX, Invasive Pressure & Temperature OptionsPhilips Medical Systems · 2006 · cites it directly4descendants
- K130153Hearstart MRX with Airway Confimration AssistPhilips Medical Systems · 2013 · 2 generations on2descendants
- K133659Heartstart XL+Defibrillator/Monitor with End-Tidal Carbon Dioxide MonitoringPhilips Medical Systems · 2015 · 3 generations on1descendant
- K200849Tempus LS - ManualRemote Diagnostic Technologies, Ltd. A Philips Company · 2020 · 4 generations on0descendants
- K063375Heartstart MRX, Models M3535A or M3536APhilips Medical Systems · 2007 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K011865 | Zoll M Series Ibp Operation; Zoll M Series Temperature Option | Zoll Medical Corp | 2001 | — |
| +1 | K061707 | Heartstart MRX, Invasive Pressure & Temperature Options | Philips Medical Systems | 2006 | Class I |
| +2 | K130153 | Hearstart MRX with Airway Confimration Assist | Philips Medical Systems | 2013 | — |
| +3 | K133659 | Heartstart XL+Defibrillator/Monitor with End-Tidal Carbon Dioxide Monitoring | Philips Medical Systems | 2015 | — |
| +4 | K200849 | Tempus LS - Manual | Remote Diagnostic Technologies, Ltd. A Philips Company | 2020 | 4 |
| +2 | K063375 | Heartstart MRX, Models M3535A or M3536A | Philips Medical Systems | 2007 | 11 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 1 |
| 2007 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2020 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has a Class I recall. 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 DSK device
- #1 K231586 Endophys Blood Pressure Monitor model BPM-30score 8.7 · 9 generations · no Class I recall
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K061707 | Heartstart MRX, Invasive Pressure & Temperature Options Class I | 2006 | 4 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K061707Heartstart MRX, Invasive Pressure & Temperature OptionsPhilips Medical Systems · 2006 · Cites it directly · ◆ in the 2006 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- Of its descendants, K061707 (Philips Medical Systems, 2006) has gone furthest, with 4 descendants of its own.
How does its category compare?
All DSK devicesDSK Computer, Blood-Pressure: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DSK
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · DSK
Too few DSK 510(k)s in any year since 2007 to give a median.
Recalls per year · DSK
No recall names DSK since 2007.
Adverse event reports per year · DSK
26in 2025
MAUDE reports naming product code DSK, 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 | 1 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 10 |
| 2011 | 0 | — | 0 | 5 |
| 2012 | 0 | — | 0 | 69 |
| 2013 | 0 | — | 0 | 5 |
| 2014 | 0 | — | 0 | 8 |
| 2015 | 2 | — | 0 | 7 |
| 2016 | 1 | — | 0 | 13 |
| 2017 | 0 | — | 0 | 6 |
| 2018 | 0 | — | 0 | 93 |
| 2019 | 0 | — | 0 | 148 |
| 2020 | 0 | — | 0 | 29 |
| 2021 | 0 | — | 0 | 31 |
| 2022 | 0 | — | 0 | 29 |
| 2023 | 1 | — | 0 | 14 |
| 2024 | 0 | — | 0 | 12 |
| 2025 | 0 | — | 0 | 26 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
IBP
The ZOLL M Series IBP option is indicated for measuring arterial, venous, and intracranial pressures using invasive transducers with 5uV/V/mmHg sensitivity for resting patients in critical care and transport. The M Series IBP option is intended for use with adult and pediatric patients only.
Contraindications:
The ZOLL M Series IBP option is not indicated for use on neonatal patients.
TEMPERATURE
The ZOLL M Series Temperature option is indicated for measuring temperature of adult and pediatric patients using YSI 400 compatible temperature sensors.
Contraindications:
The ZOLL M Series Temperature option is not indicated for use on neonatal patients.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K011865 · printed Nov 4, 2026
Cite this page
510(k) Report. “K011865: Zoll M Series Ibp Operation; Zoll M Series Temperature Option.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K011865
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026