510(k) · Cleared
ClearedBD Vacutainer Passive Shielding Blood Collection Needle
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 Feb 1, 2001 after an 86-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.
- Decided
- Feb 1, 2001
- Review
- 86 days
- Class
- Class II
- Product code
- FMI
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK003461 BD Vacutainer Passive Shielding Blood Collection NeedleBd Becton Dickinson Vacutainer Systems Preanalytic · 2001
- Descendant · cites it directly · 2 of its ownK072602 Vacuette Premium Safety Needle SystemMedpro Safety Products, Inc. · 2008
- Descendant · 2 generations on · 1 of its ownK111424 Vacuette Premium Safety Needle System Tube-TouchMedpro Safety Products, Inc. · 2011
- Descendant · 3 generations on · 0 of its ownK120281 Dignity Power Injectable Titanium PortMedical Components, Inc. · 2012
Most influential descendants
Showing 3 of 3 · See all- K072602Vacuette Premium Safety Needle SystemMedpro Safety Products, Inc. · 2008 · cites it directly2descendants
- K111424Vacuette Premium Safety Needle System Tube-TouchMedpro Safety Products, Inc. · 2011 · 2 generations on1descendant
- K120281Dignity Power Injectable Titanium PortMedical Components, Inc. · 2012 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K003461 | BD Vacutainer Passive Shielding Blood Collection Needle | Bd Becton Dickinson Vacutainer Systems Preanalytic | 2001 | — |
| +1 | K072602 | Vacuette Premium Safety Needle System | Medpro Safety Products, Inc. | 2008 | — |
| +2 | K111424 | Vacuette Premium Safety Needle System Tube-Touch | Medpro Safety Products, Inc. | 2011 | — |
| +3 | K120281 | Dignity Power Injectable Titanium Port | Medical Components, Inc. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 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 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K072602 | Vacuette Premium Safety Needle System | 2008 | 2 |
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, K072602 (Medpro Safety Products, Inc., 2008) has gone furthest, with 2 descendants of its own.
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) | — |
https://510kreport.com/device/K003461 · printed Nov 6, 2026
Cite this page
510(k) Report. “K003461: BD Vacutainer Passive Shielding Blood Collection Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K003461
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026