510(k) · Cleared
Recalled · Class II · 2018Disp. Transducer W/Monitoring Kit Trans
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sorensen Research · DRS Transducer, Blood-Pressure, Extravascular
Cleared on Aug 12, 1983 after a 93-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 23 later devices descend from it. It has been recalled 2 times.
- Decided
- Aug 12, 1983
- Review
- 93 days
- Class
- Class II
- Product code
- DRS
- Recalls
- 2
- Predicates
- 0
23 later devices descend from it, 1 citing it directly.
- This deviceK831506 Disp. Transducer W/Monitoring Kit TransSorensen Research · 1983
- Descendant · cites it directly · 22 of its ownK052828 Disposable Transpac Iii Integrated Transducer (IT)Hospira, Inc. · 2006 · Recalled
- Descendant · 2 generations on · 20 of its ownK061573 Transpac Iii Disposable Straight Pressure Transducer and KitHospira, Inc. · 2006 · Recalled
- Descendant · 3 generations on · 8 of its ownK171801 IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3…Philips Medizin Systeme Boeblingen GmbH · 2017 · Recalled
- Descendant · 3 generations on · 7 of its ownK091408 Disposable Pressure TransducerShenzhen Ant Hi-Tech Industrial Co., Ltd. · 2009
- Descendant · 4 generations on · 6 of its ownK181314 IntelliVue Patient Monitor MX100, IntelliVue Multi-Measurement…Philips Medizin Systeme Boeblingen GmbH · 2018
Showing 5 of 23 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 23 · See all- K052828Disposable Transpac Iii Integrated Transducer (IT)Hospira, Inc. · 2006 · cites it directly22descendants
- K061573Transpac Iii Disposable Straight Pressure Transducer and KitHospira, Inc. · 2006 · 2 generations on20descendants
- K171801IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3; intelliVue Hemodynamic…Philips Medizin Systeme Boeblingen GmbH · 2017 · 3 generations on8descendants
- K091408Disposable Pressure TransducerShenzhen Ant Hi-Tech Industrial Co., Ltd. · 2009 · 3 generations on7descendants
- K181314IntelliVue Patient Monitor MX100, IntelliVue Multi-Measurement Module X3, IntelliVue…Philips Medizin Systeme Boeblingen GmbH · 2018 · 4 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K831506 | Disp. Transducer W/Monitoring Kit Trans | Sorensen Research | 1983 | — |
| +1 | K052828 | Disposable Transpac Iii Integrated Transducer (IT) | Hospira, Inc. | 2006 | 1 |
| +2 | K061573 | Transpac Iii Disposable Straight Pressure Transducer and Kit | Hospira, Inc. | 2006 | 193 |
| +3 | K171801 | IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3; intelliVue… | Philips Medizin Systeme Boeblingen GmbH | 2017 | 4 |
| +3 | K091408 | Disposable Pressure Transducer | Shenzhen Ant Hi-Tech Industrial Co., Ltd. | 2009 | — |
| +4 | K181314 | IntelliVue Patient Monitor MX100, IntelliVue Multi-Measurement Module X3… | Philips Medizin Systeme Boeblingen GmbH | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2023 | 2 | 0 |
| 2025 | 2 | 0 |
| 2026 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DRS? 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 DRS device
- #1 K242909 FloTrac sensors; FloTrac Jr sensors; Acumen IQ…score 17.4 · 29 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (23)
See all 231 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K052828 | Disposable Transpac Iii Integrated Transducer (IT) | 2006 | 22 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 27, 2018 | Class II | Z-1072-2019 | Process design | Reports of pressure tubing separation between the sampling port and the high pressure tubing on certain lots of extravascular blood pressure transducers, which could lead to delay in therapy, and in rare circumstances, pressure tubing… |
| Jan 9, 2006 | Not classified | Z-0506-06 | Other | The I.V. administrations sets were stolen in-transit between the manufacturing site and the sterilizer, resulting in non-sterilized product possibly being on the market. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K052828 (Hospira, Inc., 2006) has gone furthest, with 22 descendants of its own.
How does its category compare?
All DRS devicesDRS Transducer, Blood-Pressure, Extravascular: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DRS
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DRS
186in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DRS
15in 2023
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · DRS
187in 2025
MAUDE reports naming product code DRS, 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 | 397 |
| 2008 | 0 | — | 0 | 531 |
| 2009 | 2 | — | 0 | 344 |
| 2010 | 2 | — | 0 | 115 |
| 2011 | 3 | 135 | 0 | 63 |
| 2012 | 1 | — | 0 | 43 |
| 2013 | 1 | — | 0 | 39 |
| 2014 | 1 | — | 0 | 23 |
| 2015 | 1 | — | 0 | 60 |
| 2016 | 3 | 186 | 162 | 89 |
| 2017 | 2 | — | 0 | 92 |
| 2018 | 0 | — | 11 | 82 |
| 2019 | 0 | — | 0 | 84 |
| 2020 | 0 | — | 0 | 41 |
| 2021 | 0 | — | 0 | 93 |
| 2022 | 0 | — | 0 | 95 |
| 2023 | 1 | — | 15 | 147 |
| 2024 | 0 | — | 0 | 205 |
| 2025 | 1 | — | 0 | 187 |
| 2026 | 1 | — | 2 (2) | — |
https://510kreport.com/device/K831506 · printed Nov 6, 2026
Cite this page
510(k) Report. “K831506: Disp. Transducer W/Monitoring Kit Trans.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K831506
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026