510(k) · Cleared
Recalled · Class II · 2018Disposable Transpac Iii Integrated Transducer (IT)
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 Feb 17, 2006 as substantially equivalent to K831506 (Sorensen Research, 1983) after a 135-day review. Its family tree reaches back 1 generation to 1983. 22 later devices descend from it. It has been recalled once.
- Decided
- Feb 17, 2006
- Review
- 135 days
- Class
- Class II
- Product code
- DRS
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K831506 (1983). 22 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK831506 Disp. Transducer W/Monitoring Kit TransSorensen Research · 1983 · Recalled
- This deviceK052828 Disposable Transpac Iii Integrated Transducer (IT)Hospira, Inc. · 2006
- Descendant · cites it directly · 20 of its ownK061573 Transpac Iii Disposable Straight Pressure Transducer and KitHospira, Inc. · 2006 · Recalled
- Descendant · 2 generations on · 8 of its ownK171801 IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3…Philips Medizin Systeme Boeblingen GmbH · 2017 · Recalled
- Descendant · 2 generations on · 7 of its ownK091408 Disposable Pressure TransducerShenzhen Ant Hi-Tech Industrial Co., Ltd. · 2009
- Descendant · 3 generations on · 6 of its ownK181314 IntelliVue Patient Monitor MX100, IntelliVue Multi-Measurement…Philips Medizin Systeme Boeblingen GmbH · 2018
- Descendant · 3 generations on · 6 of its ownK101518 Compass Vascular Access; Compass Lumbar PunctureMirador Biomedical, Inc. · 2010
Showing 5 of 22 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 22 · See all- K061573Transpac Iii Disposable Straight Pressure Transducer and KitHospira, Inc. · 2006 · cites it directly20descendants
- K171801IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3; intelliVue Hemodynamic…Philips Medizin Systeme Boeblingen GmbH · 2017 · 2 generations on8descendants
- K091408Disposable Pressure TransducerShenzhen Ant Hi-Tech Industrial Co., Ltd. · 2009 · 2 generations on7descendants
- K181314IntelliVue Patient Monitor MX100, IntelliVue Multi-Measurement Module X3, IntelliVue…Philips Medizin Systeme Boeblingen GmbH · 2018 · 3 generations on6descendants
- K101518Compass Vascular Access; Compass Lumbar PunctureMirador Biomedical, Inc. · 2010 · 3 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K831506 | Disp. Transducer W/Monitoring Kit Trans | Sorensen Research | 1983 | 2 |
| 0 (this device) | K052828 | Disposable Transpac Iii Integrated Transducer (IT) | Hospira, Inc. | 2006 | — |
| +1 | K061573 | Transpac Iii Disposable Straight Pressure Transducer and Kit | Hospira, Inc. | 2006 | 193 |
| +2 | K171801 | IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3; intelliVue… | Philips Medizin Systeme Boeblingen GmbH | 2017 | 4 |
| +2 | K091408 | Disposable Pressure Transducer | Shenzhen Ant Hi-Tech Industrial Co., Ltd. | 2009 | — |
| +3 | K181314 | IntelliVue Patient Monitor MX100, IntelliVue Multi-Measurement Module X3… | Philips Medizin Systeme Boeblingen GmbH | 2018 | — |
| +3 | K101518 | Compass Vascular Access; Compass Lumbar Puncture | Mirador Biomedical, Inc. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 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), 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? (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 |
|---|---|---|---|
| * | K831506 | Disp. Transducer W/Monitoring Kit TransSummary page 2…uivalence The Disposable Transpac® III Integrated Transducer (IT) is substantially equivalent to the predicate Transpac® Disposable Transducer with Monitoring Kit (K831506) with respect to the following characteristics: Similarities: 1) The Disposable Transpac® III Integrated Transducer… | 1983 |
What descends from it? (22)
See all 222 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 27, 2018 | Class II | Z-1071-2019 | 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… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has a recall.
- Of its descendants, K061573 (Hospira, Inc., 2006) has gone furthest, with 20 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) | — |
What is it indicated for?
The Disposable Transpac® III Integrated Transducer (IT) is intended for direct
measurement and monitoring of blood pressure. The Transpac® IllIT is intended for
one-time use.
Indications for the Disposable Transpac® III ITinclude:
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 cathterization.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052828 · printed Nov 5, 2026
Cite this page
510(k) Report. “K052828: Disposable Transpac Iii Integrated Transducer (IT).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K052828
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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