510(k) · Cleared
ClearedB-D Filter Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bd Becton Dickinson Vacutainer Systems Preanalytic · FPB Filter, Infusion Line
Cleared on Jun 20, 1980 after a 15-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 8 devices in its family, counting itself, has a Class I recall. 7 later devices descend from it.
- Decided
- Jun 20, 1980
- Review
- 15 days
- Class
- Class II
- Product code
- FPB
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 2 citing it directly. 1 of the 8 devices in this family, counting this one, has a Class I recall.
- This deviceK801343 B-D Filter NeedleBd Becton Dickinson Vacutainer Systems Preanalytic · 1980
- Descendant · cites it directly · 5 of its ownK110053 Correctinject Safety System, Catheter Connector, Filter, Infusion…Smiths Medical Asd, Inc. · 2012
- Descendant · 2 generations on · 1 of its ownK170900 DASH 6 NRFit Lock Syringe + Accessories, DASH 6 NRFit Slip Syringe +…Intervene Group, Ltd. · 2017
- Descendant · 2 generations on · 1 of its ownK162219 CADD® Infusion Disposables Portfolio with NRFit™ connectorsSmiths Medical Asd, Inc. · 2017 · Recalled (Class I)
- Descendant · cites it directly · 0 of its ownK233277 Filter Needle for Single UseHangzhou Qiantang Longyue Biotechnology Co., Ltd. · 2024
- Descendant · 3 generations on · 0 of its ownK211649 PCEA Syringe SetBaxter Healthcare Corporation · 2021
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K162219 CADD® Infusion Disposables Portfolio with NRFit™…2 generations on · 2017
Most influential descendants
Showing 5 of 7 · See all- K110053Correctinject Safety System, Catheter Connector, Filter, Infusion Adaptor, Syringe KitSmiths Medical Asd, Inc. · 2012 · cites it directly5descendants
- K170900DASH 6 NRFit Lock Syringe + Accessories, DASH 6 NRFit Slip Syringe + Accessories, DASH 6…Intervene Group, Ltd. · 2017 · 2 generations on1descendant
- K162219CADD® Infusion Disposables Portfolio with NRFit™ connectorsSmiths Medical Asd, Inc. · 2017 · 2 generations on1descendant
- K233277Filter Needle for Single UseHangzhou Qiantang Longyue Biotechnology Co., Ltd. · 2024 · cites it directly0descendants
- K211649PCEA Syringe SetBaxter Healthcare Corporation · 2021 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K801343 | B-D Filter Needle | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1980 | — |
| +1 | K110053 | Correctinject Safety System, Catheter Connector, Filter, Infusion Adaptor… | Smiths Medical Asd, Inc. | 2012 | — |
| +2 | K170900 | DASH 6 NRFit Lock Syringe + Accessories, DASH 6 NRFit Slip Syringe +… | Intervene Group, Ltd. | 2017 | — |
| +2 | K162219 | CADD® Infusion Disposables Portfolio with NRFit™ connectors | Smiths Medical Asd, Inc. | 2017 | Class I |
| +1 | K233277 | Filter Needle for Single Use | Hangzhou Qiantang Longyue Biotechnology Co., Ltd. | 2024 | — |
| +3 | K211649 | PCEA Syringe Set | Baxter Healthcare Corporation | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2017 | 2 | 1 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2024 | 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.
1 device in this family has a Class I recall. 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 FPB device
- #1 K261403 Lipipor NLF1A Infusion Filter, Lipipor NLF2A &…score 11.9 · 1 generation · no Class I recall
- #2 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? (7)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K162219CADD® Infusion Disposables Portfolio with NRFit™ connectorsSmiths Medical Asd, Inc. · 2017 · 2 generations on · ◆ in the 2017 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K110053 (Smiths Medical Asd, Inc., 2012) has gone furthest, with 5 descendants of its own.
How does its category compare?
All FPB devicesFPB Filter, Infusion Line: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FPB
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · FPB
Too few FPB 510(k)s in any year since 2007 to give a median.
Recalls per year · FPB
1in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FPB
33in 2025
MAUDE reports naming product code FPB, 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 | 14 |
| 2008 | 0 | — | 0 | 44 |
| 2009 | 0 | — | 0 | 33 |
| 2010 | 0 | — | 0 | 32 |
| 2011 | 1 | — | 1 | 20 |
| 2012 | 0 | — | 0 | 21 |
| 2013 | 0 | — | 0 | 44 |
| 2014 | 0 | — | 0 | 67 |
| 2015 | 1 | — | 0 | 25 |
| 2016 | 0 | — | 0 | 95 |
| 2017 | 0 | — | 0 | 53 |
| 2018 | 0 | — | 0 | 35 |
| 2019 | 0 | — | 0 | 31 |
| 2020 | 0 | — | 0 | 18 |
| 2021 | 0 | — | 0 | 160 |
| 2022 | 0 | — | 0 | 36 |
| 2023 | 0 | — | 0 | 39 |
| 2024 | 1 | — | 0 | 47 |
| 2025 | 0 | — | 0 | 33 |
| 2026 | 1 | — | 0 | — |
https://510kreport.com/device/K801343 · printed Nov 5, 2026
Cite this page
510(k) Report. “K801343: B-D Filter Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K801343
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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