510(k) · Cleared
ClearedTransmitter, ZS-940PA Series
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nihon Kohden America, Inc. · DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
Cleared on Feb 3, 2005 after a 45-day review. The FDA summary names its predicate without a number. 65 later devices descend from it.
- Decided
- Feb 3, 2005
- Review
- 45 days
- Class
- Class II
- Product code
- DRT
- Recalls
- None
- Predicates
- 0
65 later devices descend from it, 3 citing it directly.
- This deviceK043517 Transmitter, ZS-940PA SeriesNihon Kohden America, Inc. · 2005
- Descendant · cites it directly · 37 of its ownK101600 Intellivue CL SP02 Pod Model 865215, Intellivue CL NBP Pod Model…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2010
- Descendant · 2 generations on · 36 of its ownK111905 Intellivue Guardian Software Model 866009, Intellivue CL SP02 Pod…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2011
- Descendant · 3 generations on · 35 of its ownK122223 New: Intellivue CL Respiration Pod New: Specialized Assessory…Philips Medizin Systeme Boeblingen GmbH · 2013
- Descendant · 4 generations on · 24 of its ownK151736 Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boblingen GmbH · 2015
- Descendant · cites it directly · 24 of its ownK112478 Visi Mobile Monitoring SystemSotera Wireless, Inc. · 2012 · Recalled
Showing 5 of 65 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 65 · See all- K101600Intellivue CL SP02 Pod Model 865215, Intellivue CL NBP Pod Model 865216, Intellivue…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2010 · cites it directly37descendants
- K111905Intellivue Guardian Software Model 866009, Intellivue CL SP02 Pod Model 865215…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2011 · 2 generations on36descendants
- K122223New: Intellivue CL Respiration Pod New: Specialized Assessory: Mobile CL Resp Attachment…Philips Medizin Systeme Boeblingen GmbH · 2013 · 3 generations on35descendants
- K151736Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boblingen GmbH · 2015 · 4 generations on24descendants
- K112478Visi Mobile Monitoring SystemSotera Wireless, Inc. · 2012 · cites it directly24descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K043517 | Transmitter, ZS-940PA Series | Nihon Kohden America, Inc. | 2005 | — |
| +1 | K101600 | Intellivue CL SP02 Pod Model 865215, Intellivue CL NBP Pod Model 865216… | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2010 | — |
| +2 | K111905 | Intellivue Guardian Software Model 866009, Intellivue CL SP02 Pod Model… | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2011 | — |
| +3 | K122223 | New: Intellivue CL Respiration Pod New: Specialized Assessory: Mobile CL Resp… | Philips Medizin Systeme Boeblingen GmbH | 2013 | — |
| +4 | K151736 | Philips IntelliVue GuardianSoftware | Philips Medizin Systeme Boblingen GmbH | 2015 | — |
| +1 | K112478 | Visi Mobile Monitoring System | Sotera Wireless, Inc. | 2012 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 4 | 0 |
| 2014 | 1 | 0 |
| 2015 | 7 | 0 |
| 2016 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 7 | 0 |
| 2019 | 4 | 0 |
| 2020 | 3 | 0 |
| 2021 | 3 | 0 |
| 2022 | 5 | 0 |
| 2023 | 5 | 0 |
| 2024 | 7 | 0 |
| 2025 | 9 | 0 |
| 2026 | 2 | 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 DRT? 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 DRT device
- #1 K252676 The Circadia C300 System (C300)score 15.3 · 6 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 |
|---|---|---|---|
| * | — | Nihon Kohden predicate devices Named without a submission number |
What descends from it? (65)
See all 653 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?
- Of its descendants, K101600 (Philips Medizinsysteme Boeblingen GmbH, Cardiac AN, 2010) has gone furthest, with 37 descendants of its own.
How does its category compare?
All DRT devicesDRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DRT
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DRT
228in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DRT
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DRT
40in 2025
MAUDE reports naming product code DRT, 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 | 113 |
| 2008 | 1 | — | 0 | 99 |
| 2009 | 6 | 70 | 0 | 118 |
| 2010 | 3 | 44 | 0 | 63 |
| 2011 | 3 | 149 | 1 | 36 |
| 2012 | 1 | — | 0 | 47 |
| 2013 | 1 | — | 0 | 16 |
| 2014 | 0 | — | 0 | 26 |
| 2015 | 1 | — | 0 | 48 |
| 2016 | 1 | — | 0 | 55 |
| 2017 | 1 | — | 0 | 159 |
| 2018 | 1 | — | 0 | 224 |
| 2019 | 1 | — | 0 | 447 |
| 2020 | 0 | — | 0 | 50 |
| 2021 | 2 | — | 1 | 85 |
| 2022 | 1 | — | 0 | 35 |
| 2023 | 1 | — | 0 | 47 |
| 2024 | 3 | 228 | 1 | 29 |
| 2025 | 1 | — | 0 | 40 |
| 2026 | 5 | 120 | 0 | — |
What is it indicated for?
The device is intended to transmit physiological data, such as: ele6trocardiogram (ECG), respiration, blood oxygen saturation (SpO2), noninvasive blood pressure (NIBP), and pulse waveform from a patient to a Nihon Kohden monitor for continuous monitoring. The transmitter can change channels when connected to the QI-9OPK channel writer. The front LCD displays SPO2%, NlBP, pulse rate, pulse waveform amplitude, electrode condition mark, battery condition…
Read the full statement (119 words)
The device is intended to transmit physiological data, such as: ele6trocardiogram (ECG), respiration, blood oxygen saturation (SpO2), noninvasive blood pressure (NIBP), and pulse waveform from a patient to a Nihon Kohden monitor for continuous monitoring. The transmitter can change channels when connected to the QI-9OPK channel writer. The front LCD displays SPO2%, NlBP, pulse rate, pulse waveform amplitude, electrode condition mark, battery condition and NIBP measuring mode and interval. The system communicates in the new WMTS band as required by FCC. The device will be available for use within a medical facility, including ICU, CCU, recovery room and general ward by medical personnel on adults and children for NIBP and all other functions for all patient populations, including neonates.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043517 · printed Nov 5, 2026
Cite this page
510(k) Report. “K043517: Transmitter, ZS-940PA Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K043517
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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