510(k) · Cleared
ClearedProsim 4, Prosim 6, Prosim 8
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fluke Biomedical · DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
Cleared on Sep 2, 2011 as substantially equivalent to K935817 (Dynatech/Nevada, Inc., 1994) and 1 other predicate after a 199-day review. Its family tree reaches back 1 generation to 1994.
- Decided
- Sep 2, 2011
- Review
- 199 days
- Class
- Class II
- Product code
- DRT
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K935817 (1994). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK935817 Medsim 300 Patient SimulatorDynatech/Nevada, Inc. · 1994
- This deviceK110429 Prosim 4, Prosim 6, Prosim 8Fluke Biomedical · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K935817 | Medsim 300 Patient Simulator | Dynatech/Nevada, Inc. | 1994 | — |
| 0 (this device) | K110429 | Prosim 4, Prosim 6, Prosim 8 | Fluke Biomedical | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 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 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? (4)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K935817 | Medsim 300 Patient SimulatorSummary page 1…CER 870.2300/870.1130 " Product Codes -DRT, DXN Devices for Which Substantial Equivalence is Claimed: * MedSim300B -Submitted as MedSim300 under 5 10(k) K935817 * Cufflink Device Description: Principles of Operation Fluke Biomedical's ProSim 4 (hereafter refer-red to as the ProSi… | 1994 |
| * | K933519 | Index SPO2 SimulatorSummary page 7…tial Equivalence is Claimed: * MedSim300B; _Submitted as MedSim300 under 5 10(k) K935817 * Index 2MF SPO2 - Originally submitted and cleared under 5 10(k) K9335 19. Currently marketed as Index 2MF which was ruled as a general purpose device on Feb 11, 1998 (K974293) * Cufflink… | 1994 |
| Kept off the family tree | K974293 | Index 2 Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 7…2MF SPO2 - Originally submitted and cleared under 5 10(k) K9335 19. Currently marketed as Index 2MF which was ruled as a general purpose device on Feb 11, 1998 (K974293) * Cufflink Device Description: Principles of Operation Fluke Biomedical's ProSim 6 and ProSim 8 (hereafter referred to… | |
| * | — | Cufflink Named without a submission number |
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?
- None of the 2 ancestors has a recall.
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. 2011, this device’s year, is highlighted.
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 ProSim 4 Vital Signs Simulator provides electronic and pneumatic simulation of physiological parameters for determining that patient monitoring devices or systems are performing within their operating specifications. The device includes the following physiological simulations: * ECG - adult or neonatal * Invasive and non-invasive blood pressure * Respiration The ProSim 6 and ProSim 8 Vital Signs Simulators provide electronic and pneumatic simulation…
Read the full statement (139 words)
The ProSim 4 Vital Signs Simulator provides electronic and pneumatic simulation of physiological parameters for determining that patient monitoring devices or systems are performing within their operating specifications. The device includes the following physiological simulations:
* ECG - adult or neonatal
* Invasive and non-invasive blood pressure
* Respiration
The ProSim 6 and ProSim 8 Vital Signs Simulators provide electronic and pneumatic simulation of physiological parameters for determining that patient monitoring devices or systems are performing within their operating specifications. The devices provide the following physiological simulations:
* ECG - adult or pediatric
* Invasive and non-invasive blood pressure
* Respiration
* Temperature
* Cardiac Output
* Fetal Simulation - includes fetal, maternal ECG, & uterine contractions (ProSim 8 only)
Additionally, the devices provide an optical signal to verify that the electronics within the pulse oximeter probe are functional
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110429 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110429: Prosim 4, Prosim 6, Prosim 8.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110429
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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