510(k) · Cleared
ClearedElcam Disposable Integrated Pressure Transducer (Dipt)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Elcam Medical Acal · DRS Transducer, Blood-Pressure, Extravascular
Cleared on Jun 8, 2012 as substantially equivalent to K052828 (Hospira, Inc., 2006) after a 99-day review. Its family tree reaches back 2 generations to 1983.
- Decided
- Jun 8, 2012
- Review
- 99 days
- Class
- Class II
- Product code
- DRS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K831506 (1983). No later device cites it as a predicate yet.
- 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 deviceK120624 Elcam Disposable Integrated Pressure Transducer (Dipt)Elcam Medical Acal · 2012
View FIG. 1 as a table
Line of descent and top descendants
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 |
|---|---|---|---|
| * | K052828 | Disposable Transpac Iii Integrated Transducer (IT)Summary page 1…gulation: 21 CFR § 870.2850 Regulatory Class: 11 Identification of Legally Marketed Predicate Devices Hospira Disposable integrated pressure transducer - K052828 Device Description The disposable Transducer in an extravascular blood pressure transducer that convert mechanical changes in pr… | 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 29 years and passes through 3 companies; a new generation was cleared every 22.5 years on median.
- 2 of the 2 ancestors have a recall of any class.
- 1 other device also cites its predicate K052828.
How does its category compare?
All DRS devicesDRS Transducer, Blood-Pressure, Extravascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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?
Elcam Disposable Integrated Pressure Transducer is intended for direct measurement and monitoring of blood pressure. The disposable Transducer is intended for single use only.
Indications for the Disposable Integrated Pressure Transducer (DIPT) include:
- Direct arterial blood pressure monitoring - central and peripheral
- Pulmonary artery monitoring
- Venous pressure monitoring
- Left atrial monitoring when used with an air eliminator
- Cardiac catheterization
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120624 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120624: Elcam Disposable Integrated Pressure Transducer (Dipt).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120624
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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