510(k) · Cleared
ClearedSafety Blood Collection / Infusion Set (with/without needle holder), Blood Collection / Infusion Set (with/without needle holder)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. · FMI Needle, Hypodermic, Single Lumen
Cleared on Apr 12, 2022 as substantially equivalent to K173757 (Greiner Bio-One Na, Inc., 2018) after a 106-day review. Its family tree reaches back 5 generations to 1991. 1 later device descends from it.
- Decided
- Apr 12, 2022
- Review
- 106 days
- Class
- Class II
- Product code
- FMI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K912563 (1991). 6 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK912563 Angel Wing Safety Blood Collection and Infusion SEMbo Laboratories, Inc. · 1991
- 4 generations backK011786 Vacuette Safety Blood Collection SetGreiner Vacuette North America, Inc. · 2001 · Recalled
- 3 generations backK080235 Safety Infusion SetGreiner Bio-One Vacuette North America · 2008
- 2 generations backK121908 Safety Infusion SetGreiner Bio-One North America, Inc. · 2012
- 1 generation backK173757 VACUETTE EVOPROTECT Safety Blood Collection / Infusion SetGreiner Bio-One Na, Inc. · 2018
- This deviceK214075 Safety Blood Collection / Infusion Set (with/without needle holder)…Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK232881 Winged Infusion Set, Safety Winged Infusion Set, Blood Collection…Jiangsu Kangbao Medical Equipment Co., Ltd. · 2023
Most influential descendants
Showing 1 of 1 · See all- K232881Winged Infusion Set, Safety Winged Infusion Set, Blood Collection Set, Blood Collection…Jiangsu Kangbao Medical Equipment Co., Ltd. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K912563 | Angel Wing Safety Blood Collection and Infusion SE | Mbo Laboratories, Inc. | 1991 | — |
| −4 | K011786 | Vacuette Safety Blood Collection Set | Greiner Vacuette North America, Inc. | 2001 | 2 |
| −3 | K080235 | Safety Infusion Set | Greiner Bio-One Vacuette North America | 2008 | — |
| −2 | K121908 | Safety Infusion Set | Greiner Bio-One North America, Inc. | 2012 | — |
| −1 | K173757 | VACUETTE EVOPROTECT Safety Blood Collection / Infusion Set | Greiner Bio-One Na, Inc. | 2018 | — |
| 0 (this device) | K214075 | Safety Blood Collection / Infusion Set (with/without needle holder), Blood… | Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. | 2022 | — |
| +1 | 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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K173757 | VACUETTE EVOPROTECT Safety Blood Collection / Infusion SetSummary page 4…er(s): 21CFR 880.5570 Product Code: FMI, FPA Device Class: Class II Predicate Device: K173757 VACUETTE EVOPROTECT Safety Blood Collection/Infusion Se… | 2018 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K232881 | Winged Infusion Set, Safety Winged Infusion Set, Blood Collection Set, Blood Collection… | 2023 | 0 |
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 31 years and passes through 6 companies; a new generation was cleared every 5.7 years on median.
- 2 of the 6 ancestors have a recall of any class.
- Of its descendants, K232881 (Jiangsu Kangbao Medical Equipment Co., Ltd., 2023) has gone furthest, with 0 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. 2022, 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 Safety Blood Collection / Infusion Set (with/without needle holder) is indicated for venous blood collection and/or the short-term infusion of intravenous fluids for 2 hours or less. It is to be used by appropriately trained healthcare professionals in accordance with the instructions. The safety shield is intended to aid in the protection against accidental needle stick injury.
The Blood Collection / Infusion Set (with/without needle holder) is indicated for venous blood collection and/or the short-term infusion of intravenous fluids for 2 hours or less. 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/K214075 · printed Nov 4, 2026
Cite this page
510(k) Report. “K214075: Safety Blood Collection / Infusion Set (with/without needle holder), Blood Collection / Infusion Set (with/without needle holder).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K214075
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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