510(k) · Cleared
ClearedBecton Dickinson Twinpak
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bd Becton Dickinson Vacutainer Systems Preanalytic · FMI Needle, Hypodermic, Single Lumen
Cleared on Jan 22, 1998 as substantially equivalent to K920422 (Bd Becton Dickinson Vacutainer Systems Preanalytic, 1992) after a 93-day review. Its family tree reaches back 1 generation to 1992. 4 later devices descend from it.
- Decided
- Jan 22, 1998
- Review
- 93 days
- Class
- Class II
- Product code
- FMI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K920422 (1992). 4 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK920422 B-D Interlink Syringe CannulaBd Becton Dickinson Vacutainer Systems Preanalytic · 1992
- This deviceK974006 Becton Dickinson TwinpakBd Becton Dickinson Vacutainer Systems Preanalytic · 1998
- Descendant · cites it directly · 1 of its ownK170900 DASH 6 NRFit Lock Syringe + Accessories, DASH 6 NRFit Slip Syringe +…Intervene Group, Ltd. · 2017
- Descendant · cites it directly · 1 of its ownK102328 Blunt Fill Needle and Blunt Plastic CannulaShandong Weigao Group Medical Polymer Co., Ltd. · 2011
- Descendant · 2 generations on · 0 of its ownK201031 NRFit® Caps, Male and Female Neuraxial Tip CapsInternational Medical Industries, Inc. · 2020
- Descendant · 2 generations on · 0 of its ownK120420 Sterile Blunt for Single UseShanghai Double Dove Industrial Co., Ltd. · 2012
Most influential descendants
Showing 4 of 4 · See all- K170900DASH 6 NRFit Lock Syringe + Accessories, DASH 6 NRFit Slip Syringe + Accessories, DASH 6…Intervene Group, Ltd. · 2017 · cites it directly1descendant
- K102328Blunt Fill Needle and Blunt Plastic CannulaShandong Weigao Group Medical Polymer Co., Ltd. · 2011 · cites it directly1descendant
- K201031NRFit® Caps, Male and Female Neuraxial Tip CapsInternational Medical Industries, Inc. · 2020 · 2 generations on0descendants
- K120420Sterile Blunt for Single UseShanghai Double Dove Industrial Co., Ltd. · 2012 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K920422 | B-D Interlink Syringe Cannula | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1992 | — |
| 0 (this device) | K974006 | Becton Dickinson Twinpak | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1998 | — |
| +1 | K170900 | DASH 6 NRFit Lock Syringe + Accessories, DASH 6 NRFit Slip Syringe +… | Intervene Group, Ltd. | 2017 | — |
| +1 | K102328 | Blunt Fill Needle and Blunt Plastic Cannula | Shandong Weigao Group Medical Polymer Co., Ltd. | 2011 | — |
| +2 | K201031 | NRFit® Caps, Male and Female Neuraxial Tip Caps | International Medical Industries, Inc. | 2020 | — |
| +2 | K120420 | Sterile Blunt for Single Use | Shanghai Double Dove Industrial Co., Ltd. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
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 FMI? 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 FMI device
- #1 K252886 Pen Needlescore 14.5 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K920422 | B-D Interlink Syringe CannulaSummary page 2…e following products are referenced as predicate devices: Device . 510(K) # Becton Dickinson 20G ic needle Pre-amendment device o Becton Dickinson Intedink® Vial Access K920422 and K8835838 Cannula — Becton Dickinson Tubing Adapter Pre-amendment device These products are compared to the syringe filling d… | 1992 |
| Kept off the family tree | K883583 | Becton Dickinson Interlink® Vial Access Cannula Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 2…products are referenced as predicate devices: Device . 510(K) # Becton Dickinson 20G ic needle Pre-amendment device o Becton Dickinson Intedink® Vial Access K920422 and K8835838 Cannula — Becton Dickinson Tubing Adapter Pre-amendment device These products are compared to the syringe filling device of B-D… | |
| * | — | Becton Dickinson 20G hypodermic needle Named without a submission number | |
| * | — | Becton Dickinson Tubing Adapter Named without a submission number |
What descends from it? (4)
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?
How does its category compare?
All FMI devicesFMI Needle, Hypodermic, Single Lumen: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FMI
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FMI
141in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FMI
1in 2024
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · FMI
2,424in 2025
MAUDE reports naming product code FMI, 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 | 15 | 71 | 2 | 208 |
| 2008 | 10 | 85 | 4 | 177 |
| 2009 | 7 | 177 | 3 | 263 |
| 2010 | 15 | 119 | 79 | 249 |
| 2011 | 12 | 113 | 5 | 240 |
| 2012 | 17 | 107 | 1 | 215 |
| 2013 | 11 | 87 | 1 | 255 |
| 2014 | 14 | 155 | 3 | 287 |
| 2015 | 10 | 89 | 1 | 567 |
| 2016 | 20 | 217 | 0 | 941 |
| 2017 | 9 | 253 | 16 | 1,547 |
| 2018 | 20 | 176 | 0 | 2,398 |
| 2019 | 12 | 186 | 5 | 4,896 |
| 2020 | 11 | 263 | 3 | 4,245 |
| 2021 | 18 | 143 | 7 | 4,532 |
| 2022 | 23 | 189 | 0 | 4,885 |
| 2023 | 18 | 112 | 2 | 4,986 |
| 2024 | 3 | 90 | 1 | 4,053 |
| 2025 | 11 | 141 | 0 | 2,424 |
| 2026 | 12 | 119 | 1 (1) | — |
What is it indicated for?
The syringe filling device component of B-D® TWINPAK™ is for use in drawing up fluids/medications from vials and ampoules without requiring other accessories. Once the syringe is filled, the filling device is detached from the syringe. The syringe is then reattached to the blunt plastic cannula which provides access to fluid path for injection/aspiration of fluids. The B-D® TWINPAK™ offers the convenience of delivering a syringe filling device and a blunt plastic cannula for access into split septum IV sites for injection/aspiration of fluids.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K974006 · printed Nov 5, 2026
Cite this page
510(k) Report. “K974006: Becton Dickinson Twinpak.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K974006
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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