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 May 24, 2017 as substantially equivalent to K071269 (Smiths Medical Asd, Inc., 2007) and 1 other predicate after a 191-day review. Its family tree reaches back 1 generation to 1989. 2 later devices descend from it.
- Decided
- May 24, 2017
- Review
- 191 days
- Class
- Class II
- Product code
- DRS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K885281 (1989). 2 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK885281 Vamp Venous/Arterial Blood Management ProtectionBaxter Healthcare Corp · 1989 · Recalled
- This deviceK163172 HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer…Smiths Medical Asd, Inc. · 2017
- Descendant · cites it directly · 1 of its ownK172458 HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer…Smiths Medical Asd, Inc. · 2017
- Descendant · 2 generations on · 0 of its ownK221782 Meritrans ECO Reusable Pressure Transducer, Meritrans ECO DomesMerit Medical Pte., Ltd. · 2023
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K885281 | Vamp Venous/Arterial Blood Management Protection | Baxter Healthcare Corp | 1989 | 1 |
| 0 (this device) | 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 | — |
| +2 | 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 |
|---|---|---|
| 2017 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K071269 | Hemodraw Arterial Blood Sampling SystemSummary page 4…(k) Predicate Device Name Number HemoDraw Arterial Blood Sampling System K071269 VAMP Venous/Arterial Blood Management Protection K885281… | 2007 |
| * | K885281 | Vamp Venous/Arterial Blood Management ProtectionSummary page 4…Number HemoDraw Arterial Blood Sampling System K071269 VAMP Venous/Arterial Blood Management Protection K885281 Page 1 of 6… | 1989 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K172458 | HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus… | 2017 | 1 |
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?
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K172458 (Smiths Medical Asd, Inc., 2017) has gone furthest, with 1 descendant 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?
The 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. This device is for use in adults only.
The 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. This device is for use in adults only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K163172 · printed Nov 4, 2026
Cite this page
510(k) Report. “K163172: 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 4, 2026. https://510kreport.com/device/K163172
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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