510(k) · Cleared
ClearedDisposable Pressure Transducer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zhejiang Haisheng Medical Device Co., Ltd. · DRS Transducer, Blood-Pressure, Extravascular
Cleared on Oct 31, 2016 as substantially equivalent to K061573 (Hospira, Inc., 2006) after a 427-day review. Its family tree reaches back 3 generations to 1983.
- Decided
- Oct 31, 2016
- Review
- 427 days
- Class
- Class II
- Product code
- DRS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K831506 (1983). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK831506 Disp. Transducer W/Monitoring Kit TransSorensen Research · 1983 · Recalled
- 2 generations backK052828 Disposable Transpac Iii Integrated Transducer (IT)Hospira, Inc. · 2006 · Recalled
- 1 generation backK061573 Transpac Iii Disposable Straight Pressure Transducer and KitHospira, Inc. · 2006 · Recalled
- This deviceK152472 Disposable Pressure TransducerZhejiang Haisheng Medical Device Co., Ltd. · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K831506 | Disp. Transducer W/Monitoring Kit Trans | Sorensen Research | 1983 | 2 |
| −2 | K052828 | Disposable Transpac Iii Integrated Transducer (IT) | Hospira, Inc. | 2006 | 1 |
| −1 | K061573 | Transpac Iii Disposable Straight Pressure Transducer and Kit | Hospira, Inc. | 2006 | 193 |
| 0 (this device) | K152472 | Disposable Pressure Transducer | Zhejiang Haisheng Medical Device Co., Ltd. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 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 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 |
|---|---|---|---|
| * | K061573 | Transpac Iii Disposable Straight Pressure Transducer and KitSummary page 4…tification of Predicate Device(s) The identified predicates within this submission are as follows: Transpac® Disposable Straight Pressure Transducer (DSPT) as cleared in K061573. K152472 page 1 of 2 510(k) Submission 5… | 2006 |
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?
- The line of descent spans 33 years and passes through 3 companies; a new generation was cleared every 10.1 years on median.
- 4 of the 4 ancestors have a recall of any class.
- 4 other devices also cite its predicate K061573.
How does its category compare?
All DRS devicesDRS Transducer, Blood-Pressure, Extravascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
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 Blood Pressure Transducer (DBPT) is intended for direct measurement and monitoring of fluid pressure.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K152472 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152472: Disposable Pressure Transducer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152472
Report an extraction error
Are you the manufacturer?
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