510(k) · Cleared
ClearedHemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smiths Medical Asd, Inc. · DRS Transducer, Blood-Pressure, Extravascular
Cleared on Nov 9, 2017 as substantially equivalent to K163172 (Smiths Medical Asd, Inc., 2017) after an 87-day review. Its family tree reaches back 2 generations to 1989. 1 later device descends from it.
- Decided
- Nov 9, 2017
- Review
- 87 days
- Class
- Class II
- Product code
- DRS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K885281 (1989). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK885281 Vamp Venous/Arterial Blood Management ProtectionBaxter Healthcare Corp · 1989 · Recalled
- 1 generation backK163172 HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer…Smiths Medical Asd, Inc. · 2017
- This deviceK172458 HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer…Smiths Medical Asd, Inc. · 2017
- Descendant · cites it directly · 0 of its ownK221782 Meritrans ECO Reusable Pressure Transducer, Meritrans ECO DomesMerit Medical Pte., Ltd. · 2023
Most influential descendants
Showing 1 of 1 · See all- K221782Meritrans ECO Reusable Pressure Transducer, Meritrans ECO DomesMerit Medical Pte., Ltd. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K885281 | Vamp Venous/Arterial Blood Management Protection | Baxter Healthcare Corp | 1989 | 1 |
| −1 | K163172 | HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit… | Smiths Medical Asd, Inc. | 2017 | — |
| 0 (this device) | K172458 | HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit… | Smiths Medical Asd, Inc. | 2017 | — |
| +1 | 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 |
|---|---|---|
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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 |
|---|---|---|---|
| * | K163172 | HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus… Our reading of the summary gave K163712, FDA’s number for Clover 50/Clover60/Clover70 Diagnostic Ultrasound System (Shenzhen Wisonic Medical Technology Co., Ltd.), decided Jan 2, 2018, after this device. Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “HemoDraw® Plus Closed Blood Sampling Set with LogiCal®/TranStar®…”. | 2017 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K221782 | Meritrans ECO Reusable Pressure Transducer, Meritrans ECO Domes | 2023 | 0 |
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 28 years and passes through 2 companies; a new generation was cleared every 28.2 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K221782 (Merit Medical Pte., Ltd., 2023) has gone furthest, with 0 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. 2017, 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?
HemoDraw® Plus Closed Blood Sampling Set with LogiCal® Pressure Monitoring System is a hemodynamic pressure monitoring and blood sampling system designed to allow easy withdrawal of blood samples from an arterial or central venous pressure monitoring line while maintaining a completely closed system.
HemoDraw® Plus Closed Blood Sampling Set with TranStar® Pressure Monitoring System is a hemodynamic pressure monitoring and blood sampling system designed to allow easy withdrawal of blood samples from an arterial or central venous pressure monitoring line while maintaining a completely closed system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K172458 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172458: HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172458
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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