510(k) · Cleared
ClearedSafety Infusion Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Greiner Bio-One Vacuette North America · FMI Needle, Hypodermic, Single Lumen
Cleared on Apr 24, 2008 as substantially equivalent to K011297 (Nipro Medical Corp., 2001) and 1 other predicate after an 85-day review. Its family tree reaches back 2 generations to 1991. 7 later devices descend from it.
- Decided
- Apr 24, 2008
- Review
- 85 days
- Class
- Class II
- Product code
- FMI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K912563 (1991). 3 ancestors in all. 7 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK912563 Angel Wing Safety Blood Collection and Infusion SEMbo Laboratories, Inc. · 1991
- 1 generation backK011786 Vacuette Safety Blood Collection SetGreiner Vacuette North America, Inc. · 2001 · Recalled
- This deviceK080235 Safety Infusion SetGreiner Bio-One Vacuette North America · 2008
- Descendant · cites it directly · 6 of its ownK121908 Safety Infusion SetGreiner Bio-One North America, Inc. · 2012
- Descendant · 2 generations on · 2 of its ownK173757 VACUETTE EVOPROTECT Safety Blood Collection / Infusion SetGreiner Bio-One Na, Inc. · 2018
- Descendant · 2 generations on · 2 of its ownK170276 Safety Blood Collection Device for Single UseGemtier Medical (Shanghai), Inc. · 2017
- Descendant · 3 generations on · 1 of its ownK214075 Safety Blood Collection / Infusion Set (with/without needle holder)…Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. · 2022
- Descendant · 3 generations on · 1 of its ownK211293 Safety Winged Blood Collection SetsPromisemed Hangzhou Meditech Co., Ltd. · 2021
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K121908Safety Infusion SetGreiner Bio-One North America, Inc. · 2012 · cites it directly6descendants
- K173757VACUETTE EVOPROTECT Safety Blood Collection / Infusion SetGreiner Bio-One Na, Inc. · 2018 · 2 generations on2descendants
- K170276Safety Blood Collection Device for Single UseGemtier Medical (Shanghai), Inc. · 2017 · 2 generations on2descendants
- K214075Safety Blood Collection / Infusion Set (with/without needle holder), Blood Collection /…Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. · 2022 · 3 generations on1descendant
- K211293Safety Winged Blood Collection SetsPromisemed Hangzhou Meditech Co., Ltd. · 2021 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K912563 | Angel Wing Safety Blood Collection and Infusion SE | Mbo Laboratories, Inc. | 1991 | — |
| −1 | K011786 | Vacuette Safety Blood Collection Set | Greiner Vacuette North America, Inc. | 2001 | 2 |
| 0 (this device) | K080235 | Safety Infusion Set | Greiner Bio-One Vacuette North America | 2008 | — |
| +1 | K121908 | Safety Infusion Set | Greiner Bio-One North America, Inc. | 2012 | — |
| +2 | K173757 | VACUETTE EVOPROTECT Safety Blood Collection / Infusion Set | Greiner Bio-One Na, Inc. | 2018 | — |
| +2 | K170276 | Safety Blood Collection Device for Single Use | Gemtier Medical (Shanghai), Inc. | 2017 | — |
| +3 | K214075 | Safety Blood Collection / Infusion Set (with/without needle holder), Blood… | Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. | 2022 | — |
| +3 | K211293 | Safety Winged Blood Collection Sets | Promisemed Hangzhou Meditech Co., Ltd. | 2021 | — |
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 |
|---|---|---|
| 2012 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K011297 | Nipro Safetouch Scalp Vein and Blood Collection Set | 2001 |
| * | K011786 | Vacuette Safety Blood Collection SetSummary page 1…m the patient. Once the needle is covered, the safety cover locks in place. This mechanism is identical to that of the Greiner VACUETTE® Safety Blood Collection Set (K01 1786). The VACUETTE® Safety Infusion Set will be available in 2 configurations of needle gauge (21 G and 23G) and one tubing leng… | 2001 |
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K121908 | Safety Infusion Set | 2012 | 6 |
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 17 years and passes through 3 companies; a new generation was cleared every 9.8 years on median.
- 2 of the 3 ancestors have a recall of any class.
- Of its descendants, K121908 (Greiner Bio-One North America, Inc., 2012) has gone furthest, with 6 descendants of its own.
- 2 other devices also cite its predicate K011297.
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® Safety Infusion Set is a single-use, sterile, winged blood collection needle bonded to a flexible tbbing with a luer connector. The VACUETTE® Safety Infusion Set is used for blood collection and/or the short-term infusion of intravenous fluids. The winged needle is designed with a safety shield, which can be activated to cover the needle immediately following venipuncture to aid in the protection against accidental needlestick injury.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080235 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080235: Safety Infusion Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080235
Report an extraction error
Are you the manufacturer?
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