510(k) · Cleared
ClearedQS90 Smooth E Arterial Blood Sampler
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Radiometer America, Inc. · GIM Tubes, Vacuum Sample, With Anticoagulant
Cleared on Jan 23, 1990 after a 70-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 later devices descend from it.
- Decided
- Jan 23, 1990
- Review
- 70 days
- Class
- Class II
- Product code
- GIM
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 2 citing it directly.
- This deviceK896514 QS90 Smooth E Arterial Blood SamplerRadiometer America, Inc. · 1990
- Descendant · cites it directly · 3 of its ownK982922 Vacutainer Brand Blood Collection SyringeBecton Dickinson Vacutainer Systems · 1998
- Descendant · 2 generations on · 2 of its ownK022426 BD Preset Blood Collection Syringe, BD a-Line Blood Collection…Becton, Dickinson & CO · 2002
- Descendant · cites it directly · 1 of its ownK962158 Pico Models 30, 50, 70Radiometer America, Inc. · 1996 · Recalled
- Descendant · 3 generations on · 0 of its ownK260128 BD Preset™ and BD A-Line™ Arterial Blood Collection SyringesBecton, Dickinson and Company · 2026
- Descendant · 3 generations on · 0 of its ownK202446 BD Preset Syringe & BD A-Line SyringeBecton, Dickinson and Company · 2020
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K982922Vacutainer Brand Blood Collection SyringeBecton Dickinson Vacutainer Systems · 1998 · cites it directly3descendants
- K022426BD Preset Blood Collection Syringe, BD a-Line Blood Collection Syringe, Models 365313…Becton, Dickinson & CO · 2002 · 2 generations on2descendants
- K962158Pico Models 30, 50, 70Radiometer America, Inc. · 1996 · cites it directly1descendant
- K260128BD Preset™ and BD A-Line™ Arterial Blood Collection SyringesBecton, Dickinson and Company · 2026 · 3 generations on0descendants
- K202446BD Preset Syringe & BD A-Line SyringeBecton, Dickinson and Company · 2020 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K896514 | QS90 Smooth E Arterial Blood Sampler | Radiometer America, Inc. | 1990 | — |
| +1 | K982922 | Vacutainer Brand Blood Collection Syringe | Becton Dickinson Vacutainer Systems | 1998 | — |
| +2 | K022426 | BD Preset Blood Collection Syringe, BD a-Line Blood Collection Syringe, Models… | Becton, Dickinson & CO | 2002 | — |
| +1 | K962158 | Pico Models 30, 50, 70 | Radiometer America, Inc. | 1996 | 1 |
| +3 | K260128 | BD Preset™ and BD A-Line™ Arterial Blood Collection Syringes | Becton, Dickinson and Company | 2026 | — |
| +3 | K202446 | BD Preset Syringe & BD A-Line Syringe | Becton, Dickinson and Company | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
| 2020 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GIM? 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 GIM device
- #1 K240455 BD Vacutainer® Citrate Blood Collection Tubesscore 8.3 · 1 generation · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (6)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K982922 (Becton Dickinson Vacutainer Systems, 1998) has gone furthest, with 3 descendants of its own.
How does its category compare?
All GIM devicesGIM Tubes, Vacuum Sample, With Anticoagulant: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GIM
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · GIM
Too few GIM 510(k)s in any year since 2007 to give a median.
Recalls per year · GIM
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GIM
641in 2025
MAUDE reports naming product code GIM, 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 | 0 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 1 | 3 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 2 |
| 2017 | 1 | — | 0 | 12 |
| 2018 | 0 | — | 0 | 276 |
| 2019 | 0 | — | 0 | 145 |
| 2020 | 0 | — | 0 | 147 |
| 2021 | 0 | — | 0 | 55 |
| 2022 | 0 | — | 0 | 42 |
| 2023 | 2 | — | 0 | 33 |
| 2024 | 1 | — | 0 | 316 |
| 2025 | 0 | — | 1 | 641 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K896514 · printed Nov 4, 2026
Cite this page
510(k) Report. “K896514: QS90 Smooth E Arterial Blood Sampler.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K896514
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026