510(k) · Cleared
Recalled · Class II · 2016Transpac Iii Disposable Straight Pressure Transducer and Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hospira, Inc. · DRS Transducer, Blood-Pressure, Extravascular
Cleared on Sep 19, 2006 as substantially equivalent to K884823 (Abbott Laboratories, 1990) and 1 other predicate after a 104-day review. Its family tree reaches back 2 generations to 1983. 20 later devices descend from it. It has been recalled 193 times.
- Decided
- Sep 19, 2006
- Review
- 104 days
- Class
- Class II
- Product code
- DRS
- Recalls
- 193
- Predicates
- 2
Its longest line of descent runs back 2 generations to K831506 (1983). 3 ancestors in all. 20 later devices descend from it, 5 citing it directly.
- Root · 2 generations backK831506 Disp. Transducer W/Monitoring Kit TransSorensen Research · 1983 · Recalled
- 1 generation backK052828 Disposable Transpac Iii Integrated Transducer (IT)Hospira, Inc. · 2006 · Recalled
- This deviceK061573 Transpac Iii Disposable Straight Pressure Transducer and KitHospira, Inc. · 2006
- Descendant · cites it directly · 8 of its ownK171801 IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3…Philips Medizin Systeme Boeblingen GmbH · 2017 · Recalled
- Descendant · cites it directly · 7 of its ownK091408 Disposable Pressure TransducerShenzhen Ant Hi-Tech Industrial Co., Ltd. · 2009
- Descendant · 2 generations on · 6 of its ownK181314 IntelliVue Patient Monitor MX100, IntelliVue Multi-Measurement…Philips Medizin Systeme Boeblingen GmbH · 2018
- Descendant · 2 generations on · 6 of its ownK101518 Compass Vascular Access; Compass Lumbar PunctureMirador Biomedical, Inc. · 2010
- Descendant · 2 generations on · 5 of its ownK182979 IntelliVue Patient Monitors MX100, MX400, MX430, MX450, MX500…Philips Medizin Systeme Boeblingen GmbH · 2019
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
2009high 3 (2017) · low 0 (2012)2026
Most influential descendants
Showing 5 of 20 · See all- K171801IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3; intelliVue Hemodynamic…Philips Medizin Systeme Boeblingen GmbH · 2017 · cites it directly8descendants
- K091408Disposable Pressure TransducerShenzhen Ant Hi-Tech Industrial Co., Ltd. · 2009 · cites it directly7descendants
- K181314IntelliVue Patient Monitor MX100, IntelliVue Multi-Measurement Module X3, IntelliVue…Philips Medizin Systeme Boeblingen GmbH · 2018 · 2 generations on6descendants
- K101518Compass Vascular Access; Compass Lumbar PunctureMirador Biomedical, Inc. · 2010 · 2 generations on6descendants
- K182979IntelliVue Patient Monitors MX100, MX400, MX430, MX450, MX500, MX550, IntelliVue Patient…Philips Medizin Systeme Boeblingen GmbH · 2019 · 2 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K831506 | Disp. Transducer W/Monitoring Kit Trans | Sorensen Research | 1983 | 2 |
| −1 | K052828 | Disposable Transpac Iii Integrated Transducer (IT) | Hospira, Inc. | 2006 | 1 |
| 0 (this device) | K061573 | Transpac Iii Disposable Straight Pressure Transducer and Kit | Hospira, Inc. | 2006 | — |
| +1 | K171801 | IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3; intelliVue… | Philips Medizin Systeme Boeblingen GmbH | 2017 | 4 |
| +1 | K091408 | Disposable Pressure Transducer | Shenzhen Ant Hi-Tech Industrial Co., Ltd. | 2009 | — |
| +2 | K181314 | IntelliVue Patient Monitor MX100, IntelliVue Multi-Measurement Module X3… | Philips Medizin Systeme Boeblingen GmbH | 2018 | — |
| +2 | K101518 | Compass Vascular Access; Compass Lumbar Puncture | Mirador Biomedical, Inc. | 2010 | — |
| +2 | K182979 | IntelliVue Patient Monitors MX100, MX400, MX430, MX450, MX500, MX550… | Philips Medizin Systeme Boeblingen GmbH | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 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), 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 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? (2)
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 |
|---|---|---|---|
| * | K884823 | Transpac (R) II, Disposable TransducerSummary page 2…nded for one-time use. Summary of Substantial Equivalence The Transpac® III DSPT is substantially equivalent to the predicate Transpac® II Disposable Transducer (K884823) and Disposable Transpac® III Integrated Transducer (IT) (K052828) with respect to the following characteristics: Similari… | 1990 |
| * | K052828 | Disposable Transpac Iii Integrated Transducer (IT)Summary page 2…Transpac® III DSPT is substantially equivalent to the predicate Transpac® II Disposable Transducer (K884823) and Disposable Transpac® III Integrated Transducer (IT) (K052828) with respect to the following characteristics: Similarities: 1) The Transpac® III DSPT and predicate devices are int… | 2006 |
What descends from it? (20)
See all 205 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K171801 | IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3; intelliVue Hemodynamic… | 2017 | 8 |
| K091408 | Disposable Pressure Transducer | 2009 | 7 |
| K163376 | Mikro-Cath Pressure Catheter | 2017 | 0 |
| K152472 | Disposable Pressure Transducer | 2016 | 0 |
| K151040 | Art-line Single channel blood pressure system, Art-line Double channel blood pressure… | 2015 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 27, 2016 | Class II | Z-0449-2017 | Device Design | ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. |
| Sep 27, 2016 | Class II | Z-0450-2017 | Device Design | ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. |
| Sep 27, 2016 | Class II | Z-0429-2017 | Device Design | ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. |
| Sep 27, 2016 | Class II | Z-0438-2017 | Device Design | ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. |
| Sep 27, 2016 | Class II | Z-0452-2017 | Device Design | ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. |
| Sep 27, 2016 | Class II | Z-0422-2017 | Device Design | ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. |
| Sep 27, 2016 | Class II | Z-0461-2017 | Device Design | ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. |
| Sep 27, 2016 | Class II | Z-0440-2017 | Device Design | ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. |
| Sep 27, 2016 | Class II | Z-0453-2017 | Device Design | ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. |
| Sep 27, 2016 | Class II | Z-0456-2017 | Device Design | ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. |
| Sep 27, 2016 | Class II | Z-0437-2017 | Device Design | ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. |
| Sep 27, 2016 | Class II | Z-0465-2017 | Device Design | ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. |
| Sep 27, 2016 | Class II | Z-0420-2017 | Device Design | ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. |
| Sep 27, 2016 | Class II | Z-0446-2017 | Device Design | ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. |
| Sep 27, 2016 | Class II | Z-0435-2017 | Device Design | ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. |
| Sep 27, 2016 | Class II | Z-0439-2017 | Device Design | ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. |
| Sep 27, 2016 | Class II | Z-0425-2017 | Device Design | ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. |
| Sep 27, 2016 | Class II | Z-0443-2017 | Device Design | ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. |
| Sep 27, 2016 | Class II | Z-0426-2017 | Device Design | ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. |
| Sep 27, 2016 | Class II | Z-0468-2017 | Device Design | ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. |
| Sep 27, 2016 | Class II | Z-0448-2017 | Device Design | ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. |
| Sep 27, 2016 | Class II | Z-0451-2017 | Device Design | ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. |
| Sep 27, 2016 | Class II | Z-0430-2017 | Device Design | ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. |
| Sep 27, 2016 | Class II | Z-0462-2017 | Device Design | ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. |
| Sep 27, 2016 | Class II | Z-0463-2017 | Device Design | ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. |
| Sep 27, 2016 | Class II | Z-0427-2017 | Device Design | ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. |
| Sep 27, 2016 | Class II | Z-0466-2017 | Device Design | ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. |
| Sep 27, 2016 | Class II | Z-0416-2017 | Device Design | ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. |
| Sep 27, 2016 | Class II | Z-0415-2017 | Device Design | ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. |
| Sep 27, 2016 | Class II | Z-0432-2017 | Device Design | ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. |
| Sep 27, 2016 | Class II | Z-0444-2017 | Device Design | ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. |
| Sep 27, 2016 | Class II | Z-0421-2017 | Device Design | ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. |
| Sep 27, 2016 | Class II | Z-0447-2017 | Device Design | ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. |
| Sep 27, 2016 | Class II | Z-0424-2017 | Device Design | ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. |
| Sep 27, 2016 | Class II | Z-0434-2017 | Device Design | ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. |
| Sep 27, 2016 | Class II | Z-0423-2017 | Device Design | ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. |
| Sep 27, 2016 | Class II | Z-0460-2017 | Device Design | ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. |
| Sep 27, 2016 | Class II | Z-0436-2017 | Device Design | ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. |
| Sep 27, 2016 | Class II | Z-0442-2017 | Device Design | ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. |
| Sep 27, 2016 | Class II | Z-0428-2017 | Device Design | ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. |
| Sep 27, 2016 | Class II | Z-0445-2017 | Device Design | ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. |
| Sep 27, 2016 | Class II | Z-0418-2017 | Device Design | ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. |
| Sep 27, 2016 | Class II | Z-0467-2017 | Device Design | ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. |
| Sep 27, 2016 | Class II | Z-0433-2017 | Device Design | ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. |
| Sep 27, 2016 | Class II | Z-0441-2017 | Device Design | ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. |
| Sep 27, 2016 | Class II | Z-0417-2017 | Device Design | ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. |
| Sep 27, 2016 | Class II | Z-0419-2017 | Device Design | ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. |
| Sep 27, 2016 | Class II | Z-0431-2017 | Device Design | ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. |
| Sep 27, 2016 | Class II | Z-0464-2017 | Device Design | ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. |
| Sep 27, 2016 | Class II | Z-0414-2017 | Device Design | ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. |
The 5 latest of 50 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 23 years and passes through 2 companies; a new generation was cleared every 22.5 years on median.
- 3 of the 3 ancestors have a recall of any class.
- Of its descendants, K171801 (Philips Medizin Systeme Boeblingen GmbH, 2017) has gone furthest, with 8 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
2007high 3 (2011) · low 0 (2008)2026
2026 to Oct 25, outlined.
Median 510(k) review, days · DRS
186in 2016
2007high 186 (2016) · low 135 (2011)2026
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DRS
15in 2023
2007high 162 (2016) · low 0 (2007)2026
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · DRS
187in 2025
2007high 531 (2008) · low 23 (2014)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) | — |
What is it indicated for?
The Transpac® III Disposable Straight Pressure Transducer (DSPT) is intended for
direct measurement and monitoring of fluid pressure.
Indications for the Transpac® III DSPT include:
Intracranial Pressure Monitoring,
Intrauterine Pressure Monitoring, or
Compartmental (Intramuscular) Pressure Monitoring.
In addition, indications for the Transpac® III DSPT include:
Direct arterial blood pressure monitoring - central and peripheral,
Pulmonary artery monitoring,
Venous pressure monitoring,
Left atrial monitoring when used with an air eliminator filter, and
Cardiac catheterization.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061573 · printed Nov 4, 2026
Cite this page
510(k) Report. “K061573: Transpac Iii Disposable Straight Pressure Transducer and Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061573
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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