510(k) · Cleared
ClearedVacuette Premium Safety Needle System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medpro Safety Products, Inc. · FMI Needle, Hypodermic, Single Lumen
Cleared on Jun 18, 2008 as substantially equivalent to K003406 (International Medical Device Partners, Inc., 2001) and 1 other predicate after a 278-day review. Its family tree reaches back 1 generation to 2001. 2 later devices descend from it.
- Decided
- Jun 18, 2008
- Review
- 278 days
- Class
- Class II
- Product code
- FMI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K003406 (2001). 2 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK003406 Guarded Needle 2000International Medical Device Partners, Inc. · 2001
- This deviceK072602 Vacuette Premium Safety Needle SystemMedpro Safety Products, Inc. · 2008
- Descendant · cites it directly · 1 of its ownK111424 Vacuette Premium Safety Needle System Tube-TouchMedpro Safety Products, Inc. · 2011
- Descendant · 2 generations on · 0 of its ownK120281 Dignity Power Injectable Titanium PortMedical Components, Inc. · 2012
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K003406 | Guarded Needle 2000 | International Medical Device Partners, Inc. | 2001 | — |
| 0 (this device) | K072602 | Vacuette Premium Safety Needle System | Medpro Safety Products, Inc. | 2008 | — |
| +1 | K111424 | Vacuette Premium Safety Needle System Tube-Touch | Medpro Safety Products, Inc. | 2011 | — |
| +2 | K120281 | Dignity Power Injectable Titanium Port | Medical Components, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 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? (2)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K003406 | Guarded Needle 2000Summary page 1…eedle with antistick syringe (21 CFR 880.5570, Product Code FMI and 21 CFR 880.5860, Product Code MEG) Predicate Device: The Guarded Needle 2000 510(k) Number: K003406 Date of Concurrence: January 21, 2001 Predicate Device: BD Vacutainer Passive Shielding Blood Collection Needle 510(k) Number… | 2001 |
| * | K003461 | BD Vacutainer Passive Shielding Blood Collection NeedleSummary page 1…000 510(k) Number: K003406 Date of Concurrence: January 21, 2001 Predicate Device: BD Vacutainer Passive Shielding Blood Collection Needle 510(k) Number: K003461 Date of Concurrence: February 1,2001 Substantial Equivalence Declaration: The term "Substantial Equivalence" as used in this 510… | 2001 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K111424 | Vacuette Premium Safety Needle System Tube-Touch | 2011 | 1 |
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?
- None of the 2 ancestors has a recall.
- Of its descendants, K111424 (Medpro Safety Products, Inc., 2011) has gone furthest, with 1 descendant 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. 2008, this device’s year, is highlighted.
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 VACUETTE® Premium Safety Needle System is used in routine venipuncture procedures. The holder is designed with an integrated, multiple sample needle and safety shield. Upon insertion of the first blood collection tube, the safety shield is automatically released. The safety shield covers the needle immediately following blood collection from the patient. The product is to be used by appropriately trained healthcare professionals only in accordance with these instructions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072602 · printed Nov 6, 2026
Cite this page
510(k) Report. “K072602: Vacuette Premium Safety Needle System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K072602
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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