510(k) · Cleared
ClearedHemodraw Arterial Blood Sampling System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smiths Medical Asd, Inc. · CBT Arterial Blood Sampling Kit
Cleared on Aug 1, 2007 after an 86-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 3 later devices descend from it.
- Decided
- Aug 1, 2007
- Review
- 86 days
- Class
- Class I
- Product code
- CBT
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK071269 Hemodraw Arterial Blood Sampling SystemSmiths Medical Asd, Inc. · 2007
- Descendant · cites it directly · 2 of its ownK163172 HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer…Smiths Medical Asd, Inc. · 2017
- Descendant · 2 generations on · 1 of its ownK172458 HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer…Smiths Medical Asd, Inc. · 2017
- Descendant · 3 generations on · 0 of its ownK221782 Meritrans ECO Reusable Pressure Transducer, Meritrans ECO DomesMerit Medical Pte., Ltd. · 2023
Most influential descendants
Showing 3 of 3 · See all- K163172HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus…Smiths Medical Asd, Inc. · 2017 · cites it directly2descendants
- K172458HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus…Smiths Medical Asd, Inc. · 2017 · 2 generations on1descendant
- K221782Meritrans ECO Reusable Pressure Transducer, Meritrans ECO DomesMerit Medical Pte., Ltd. · 2023 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K071269 | Hemodraw Arterial Blood Sampling System | Smiths Medical Asd, Inc. | 2007 | — |
| +1 | K163172 | HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit… | Smiths Medical Asd, Inc. | 2017 | — |
| +2 | K172458 | HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit… | Smiths Medical Asd, Inc. | 2017 | — |
| +3 | K221782 | Meritrans ECO Reusable Pressure Transducer, Meritrans ECO Domes | Merit Medical Pte., Ltd. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 2 | 0 |
| 2023 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in CBT? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K163172 | HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus… | 2017 | 2 |
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?
- Of its descendants, K163172 (Smiths Medical Asd, Inc., 2017) has gone furthest, with 2 descendants of its own.
How does its category compare?
All CBT devicesCBT Arterial Blood Sampling Kit: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · CBT
2in 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · CBT
Too few CBT 510(k)s in any year since 2007 to give a median.
Recalls per year · CBT
14in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CBT
20in 2025
MAUDE reports naming product code CBT, 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 | 2 | — | 2 | 5 |
| 2008 | 0 | — | 0 | 10 |
| 2009 | 0 | — | 0 | 7 |
| 2010 | 0 | — | 0 | 20 |
| 2011 | 0 | — | 14 | 6 |
| 2012 | 0 | — | 0 | 14 |
| 2013 | 0 | — | 0 | 13 |
| 2014 | 0 | — | 0 | 6 |
| 2015 | 0 | — | 0 | 10 |
| 2016 | 0 | — | 0 | 30 |
| 2017 | 0 | — | 0 | 22 |
| 2018 | 0 | — | 0 | 15 |
| 2019 | 0 | — | 0 | 19 |
| 2020 | 0 | — | 0 | 10 |
| 2021 | 0 | — | 0 | 24 |
| 2022 | 0 | — | 0 | 13 |
| 2023 | 0 | — | 0 | 13 |
| 2024 | 0 | — | 0 | 25 |
| 2025 | 0 | — | 0 | 20 |
| 2026 | 0 | — | 2 | — |
What is it indicated for?
The HemoDrawTM Arterial Blood Sampling Set is a hemodynamic pressure monitoring and blood gas sampling system designed to allow easy withdrawal of blood samples from an arterial pressure monitoring line while maintaining a completely closed system.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K071269 · printed Nov 4, 2026
Cite this page
510(k) Report. “K071269: Hemodraw Arterial Blood Sampling System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071269
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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