510(k) · Cleared
ClearedVACUETTE EVOPROTECT Safety Blood Collection / Infusion Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Greiner Bio-One Na, Inc. · FMI Needle, Hypodermic, Single Lumen
Cleared on Apr 19, 2018 as substantially equivalent to K121908 (Greiner Bio-One North America, Inc., 2012) after a 129-day review. Its family tree reaches back 4 generations to 1991. 2 later devices descend from it.
- Decided
- Apr 19, 2018
- Review
- 129 days
- Class
- Class II
- Product code
- FMI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K912563 (1991). 5 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK912563 Angel Wing Safety Blood Collection and Infusion SEMbo Laboratories, Inc. · 1991
- 3 generations backK011786 Vacuette Safety Blood Collection SetGreiner Vacuette North America, Inc. · 2001 · Recalled
- 2 generations backK080235 Safety Infusion SetGreiner Bio-One Vacuette North America · 2008
- 1 generation backK121908 Safety Infusion SetGreiner Bio-One North America, Inc. · 2012
- This deviceK173757 VACUETTE EVOPROTECT Safety Blood Collection / Infusion SetGreiner Bio-One Na, Inc. · 2018
- Descendant · cites it directly · 1 of its ownK214075 Safety Blood Collection / Infusion Set (with/without needle holder)…Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. · 2022
- Descendant · 2 generations on · 0 of its ownK232881 Winged Infusion Set, Safety Winged Infusion Set, Blood Collection…Jiangsu Kangbao Medical Equipment Co., Ltd. · 2023
Most influential descendants
Showing 2 of 2 · See all- K214075Safety Blood Collection / Infusion Set (with/without needle holder), Blood Collection /…Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. · 2022 · cites it directly1descendant
- K232881Winged Infusion Set, Safety Winged Infusion Set, Blood Collection Set, Blood Collection…Jiangsu Kangbao Medical Equipment Co., Ltd. · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K912563 | Angel Wing Safety Blood Collection and Infusion SE | Mbo Laboratories, Inc. | 1991 | — |
| −3 | K011786 | Vacuette Safety Blood Collection Set | Greiner Vacuette North America, Inc. | 2001 | 2 |
| −2 | K080235 | Safety Infusion Set | Greiner Bio-One Vacuette North America | 2008 | — |
| −1 | K121908 | Safety Infusion Set | Greiner Bio-One North America, Inc. | 2012 | — |
| 0 (this device) | K173757 | VACUETTE EVOPROTECT Safety Blood Collection / Infusion Set | Greiner Bio-One Na, Inc. | 2018 | — |
| +1 | K214075 | Safety Blood Collection / Infusion Set (with/without needle holder), Blood… | Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. | 2022 | — |
| +2 | K232881 | Winged Infusion Set, Safety Winged Infusion Set, Blood Collection Set, Blood… | Jiangsu Kangbao Medical Equipment Co., Ltd. | 2023 | — |
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 |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 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 |
|---|---|---|---|
| * | K121908 | Safety Infusion SetSummary page 4…Review Panel: General Hospital 3. PREDICATE DEVICE Predicate: VACUETTE SAFETY BLOOD COLLECTION SET & SAFETY INFUSION SET (K121908) 4. DEVICE DESCRIPTION The VACUETTE® EVOPROTECT SAFETY Blood Collection/Infusion Set is a single- use, sterile, winged needle bo… | 2012 |
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 |
|---|---|---|---|
| K214075 | Safety Blood Collection / Infusion Set (with/without needle holder), Blood Collection /… | 2022 | 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?
- The line of descent spans 27 years and passes through 5 companies; a new generation was cleared every 6.8 years on median.
- 2 of the 5 ancestors have a recall of any class.
- Of its descendants, K214075 (Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd., 2022) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K121908.
How does its category compare?
All FMI devicesFMI Needle, Hypodermic, Single Lumen: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 EVOPROTECT Safety Blood Collection/Infusion Set is indicated for venous blood collection and/or the short-term infusion of intravenous fluids. It is to be used by appropriately trained healthcare professionals in accordance with the instructions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K173757 · printed Nov 4, 2026
Cite this page
510(k) Report. “K173757: VACUETTE EVOPROTECT Safety Blood Collection / Infusion Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K173757
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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