510(k) · Cleared
ClearedSecure 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 Mar 15, 2007 after a 37-day review. The FDA summary names no predicate by number.
- Decided
- Mar 15, 2007
- Review
- 37 days
- Class
- Class I
- Product code
- CBT
- Recalls
- None
- Predicates
- 0
The FDA summary names no predicate by number.
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 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?
The FDA summary names no predicate by number.
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.
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 SECURE® 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 summary.
https://510kreport.com/device/K070340 · printed Nov 3, 2026
Cite this page
510(k) Report. “K070340: Secure Arterial Blood Sampling System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K070340
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026