510(k) · Cleared
ClearedMeritrans ECO Reusable Pressure Transducer, Meritrans ECO Domes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Merit Medical Pte., Ltd. · DRS Transducer, Blood-Pressure, Extravascular
Cleared on Mar 17, 2023 as substantially equivalent to K961404 (Medex, Inc., 1996) and 1 other predicate after a 269-day review. Its family tree reaches back 3 generations to 1989.
- Decided
- Mar 17, 2023
- Review
- 269 days
- Class
- Class II
- Product code
- DRS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K885281 (1989). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK885281 Vamp Venous/Arterial Blood Management ProtectionBaxter Healthcare Corp · 1989 · Recalled
- 2 generations backK163172 HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer…Smiths Medical Asd, Inc. · 2017
- 1 generation backK172458 HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer…Smiths Medical Asd, Inc. · 2017
- This deviceK221782 Meritrans ECO Reusable Pressure Transducer, Meritrans ECO DomesMerit Medical Pte., Ltd. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K885281 | Vamp Venous/Arterial Blood Management Protection | Baxter Healthcare Corp | 1989 | 1 |
| −2 | K163172 | HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit… | Smiths Medical Asd, Inc. | 2017 | — |
| −1 | K172458 | HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit… | Smiths Medical Asd, Inc. | 2017 | — |
| 0 (this device) | K221782 | Meritrans ECO Reusable Pressure Transducer, Meritrans ECO Domes | Merit Medical Pte., Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 2007 | 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
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 |
|---|---|---|---|
| * | K961404 | MX960 Reusable Pressure TransducerSummary page 4…sable Pressure Transducer Classification Name: Transducer, Blood-Pressure, Extravascular Premarket Notification: K961404 Manufacturer: Smiths Medical ASD, Inc. (see Note 1… | 1996 |
| * | K172458 | HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus…Summary page 4…sable Pressure Transducer Classification Name: Transducer, Blood-Pressure, Extravascular Premarket Notification: K172458 K221872 Page 1 of 6 Meritrans ECO Reusable Pressure Transducer… | 2017 |
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 34 years and passes through 3 companies; a new generation was cleared every 5.3 years on median.
- 2 of the 6 ancestors have a recall of any class.
- 1 other device also cites its predicate K961404.
How does its category compare?
All DRS devicesDRS Transducer, Blood-Pressure, Extravascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 Meritrans ECO Reusable Pressure Transducer is intended to be coupled with a disposable dome kit for converting hemodynamic pressure waveforms via a piezoresistive bridge circuit into electrical signals for invasive blood pressure monitoring when connected to a patient monitor or recording device.
The devices are intended for pediatric and adult patient populations.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221782 · printed Nov 6, 2026
Cite this page
510(k) Report. “K221782: Meritrans ECO Reusable Pressure Transducer, Meritrans ECO Domes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K221782
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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