510(k) · Cleared
ClearedVacuette Visio Plus Blood Collection Needles
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Greiner Bio-One North America, Inc. · FMI Needle, Hypodermic, Single Lumen
Cleared on Aug 14, 2006 as substantially equivalent to K973620 (Greiner Meditech, Inc., 1997) after a 76-day review. Its family tree reaches back 2 generations to 1995. 5 later devices descend from it.
- Decided
- Aug 14, 2006
- Review
- 76 days
- Class
- Class II
- Product code
- FMI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K950159 (1995). 5 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK950159 SuresharpGainor Medical U.S.A., Inc. · 1995
- 1 generation backK973620 Vacuette Multi-Sample NeedleGreiner Meditech, Inc. · 1997
- This deviceK061483 Vacuette Visio Plus Blood Collection NeedlesGreiner Bio-One North America, Inc. · 2006
- Descendant · cites it directly · 1 of its ownK073127 Blood Collection Needle, Model 20G 21G 22GShandong Weigao Group Medical Polymer Co., Ltd. · 2007
- Descendant · cites it directly · 1 of its ownK072320 Greiner Vacuette Quickshield CompleteGreiner Bio-One North America, Inc. · 2007 · Recalled
- Descendant · 2 generations on · 0 of its ownK233979 VACUETTE® QUICKSHIELD Complete (Plus)Greiner Bio-One North America, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK110656 Imc Blood Collection NeedleInternational Medsurg Connection · 2011
- Descendant · 2 generations on · 0 of its ownK103587 Disposable Bllod Collection NeedleWeihai Hongyu Medical Devices Co., Ltd. · 2011
Most influential descendants
Showing 5 of 5 · See all- K073127Blood Collection Needle, Model 20G 21G 22GShandong Weigao Group Medical Polymer Co., Ltd. · 2007 · cites it directly1descendant
- K072320Greiner Vacuette Quickshield CompleteGreiner Bio-One North America, Inc. · 2007 · cites it directly1descendant
- K233979VACUETTE® QUICKSHIELD Complete (Plus)Greiner Bio-One North America, Inc. · 2024 · 2 generations on0descendants
- K110656Imc Blood Collection NeedleInternational Medsurg Connection · 2011 · cites it directly0descendants
- K103587Disposable Bllod Collection NeedleWeihai Hongyu Medical Devices Co., Ltd. · 2011 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K950159 | Suresharp | Gainor Medical U.S.A., Inc. | 1995 | — |
| −1 | K973620 | Vacuette Multi-Sample Needle | Greiner Meditech, Inc. | 1997 | — |
| 0 (this device) | K061483 | Vacuette Visio Plus Blood Collection Needles | Greiner Bio-One North America, Inc. | 2006 | — |
| +1 | K073127 | Blood Collection Needle, Model 20G 21G 22G | Shandong Weigao Group Medical Polymer Co., Ltd. | 2007 | — |
| +1 | K072320 | Greiner Vacuette Quickshield Complete | Greiner Bio-One North America, Inc. | 2007 | 1 |
| +2 | K233979 | VACUETTE® QUICKSHIELD Complete (Plus) | Greiner Bio-One North America, Inc. | 2024 | — |
| +1 | K110656 | Imc Blood Collection Needle | International Medsurg Connection | 2011 | — |
| +2 | K103587 | Disposable Bllod Collection Needle | Weihai Hongyu Medical Devices Co., Ltd. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 2 | 0 |
| 2011 | 2 | 0 |
| 2024 | 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? (1)
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 |
|---|---|---|---|
| * | K973620 | Vacuette Multi-Sample NeedleSummary page 1…lood Collection Needles Classification Name: Needle, Hypodermic, Single Lumen PREDICATE DEVICE: Greiner VACUETTE® Multi-Sample Needle (K973620) DEVICE DESCRIPTION: INTENDED USE: VACUETTE® VISIO PLUS Blood Collection Needles are designed for use in the daily… | 1997 |
What descends from it? (5)
3 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?
- The line of descent spans 11 years and passes through 3 companies; a new generation was cleared every 8.7 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K073127 (Shandong Weigao Group Medical Polymer Co., Ltd., 2007) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K973620.
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?
VACUETTE® VISIO PLUS Blood Collection Needles are designed for use in the daily blood collection routine when delegated by a qualified practitioner.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061483 · printed Nov 5, 2026
Cite this page
510(k) Report. “K061483: Vacuette Visio Plus Blood Collection Needles.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K061483
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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