510(k) · Cleared
ClearedCiba Corning Balanced Heparin for CA++
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ciba Corning Diagnostics Corp. · CBT Arterial Blood Sampling Kit
Cleared on Feb 29, 1988 after a 76-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it.
- Decided
- Feb 29, 1988
- Review
- 76 days
- Class
- Class I
- Product code
- CBT
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 1 citing it directly.
- This deviceK875117 Ciba Corning Balanced Heparin for CA++Ciba Corning Diagnostics Corp. · 1988
- 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 · 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
Most influential descendants
Showing 4 of 4 · 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
- 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) | K875117 | Ciba Corning Balanced Heparin for CA++ | Ciba Corning Diagnostics Corp. | 1988 | — |
| +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 | — |
| +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 |
|---|---|---|
| 1998 | 1 | 0 |
| 2002 | 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 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K982922 | Vacutainer Brand Blood Collection Syringe | 1998 | 3 |
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 CBT devicesCBT Arterial Blood Sampling Kit: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 | — |
https://510kreport.com/device/K875117 · printed Nov 6, 2026
Cite this page
510(k) Report. “K875117: Ciba Corning Balanced Heparin for CA++.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K875117
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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