510(k) · Cleared
ClearedSafety Winged Blood Collection Sets
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Promisemed Hangzhou Meditech Co., Ltd. · FMI Needle, Hypodermic, Single Lumen
Cleared on Jan 10, 2025 as substantially equivalent to K211293 (Promisemed Hangzhou Meditech Co., Ltd., 2021) after a 30-day review. Its family tree reaches back 6 generations to 1991.
- Decided
- Jan 10, 2025
- Review
- 30 days
- Class
- Class II
- Product code
- FMI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K912563 (1991). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK912563 Angel Wing Safety Blood Collection and Infusion SEMbo Laboratories, Inc. · 1991
- 5 generations backK011786 Vacuette Safety Blood Collection SetGreiner Vacuette North America, Inc. · 2001 · Recalled
- 4 generations backK080235 Safety Infusion SetGreiner Bio-One Vacuette North America · 2008
- 3 generations backK121908 Safety Infusion SetGreiner Bio-One North America, Inc. · 2012
- 2 generations backK170276 Safety Blood Collection Device for Single UseGemtier Medical (Shanghai), Inc. · 2017
- 1 generation backK211293 Safety Winged Blood Collection SetsPromisemed Hangzhou Meditech Co., Ltd. · 2021
- This deviceK243806 Safety Winged Blood Collection SetsPromisemed Hangzhou Meditech Co., Ltd. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K912563 | Angel Wing Safety Blood Collection and Infusion SE | Mbo Laboratories, Inc. | 1991 | — |
| −5 | K011786 | Vacuette Safety Blood Collection Set | Greiner Vacuette North America, Inc. | 2001 | 2 |
| −4 | K080235 | Safety Infusion Set | Greiner Bio-One Vacuette North America | 2008 | — |
| −3 | K121908 | Safety Infusion Set | Greiner Bio-One North America, Inc. | 2012 | — |
| −2 | K170276 | Safety Blood Collection Device for Single Use | Gemtier Medical (Shanghai), Inc. | 2017 | — |
| −1 | K211293 | Safety Winged Blood Collection Sets | Promisemed Hangzhou Meditech Co., Ltd. | 2021 | — |
| 0 (this device) | K243806 | Safety Winged Blood Collection Sets | Promisemed Hangzhou Meditech Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 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 |
|---|---|---|---|
| * | K211293 | Safety Winged Blood Collection SetsSummary page 5…ode FMI, FPA 3. Legally Marketed Predicate Device [21 CFR 807.92 (a) (3)] Predicate Name Safety Winged Blood Collection Sets 510(k) Number K211293 Product Code FMI, FPA Reference Devices No reference devices were used in this submission. 4. Device Descriptio… | 2021 |
| † | K230715 | Promisemed Safety Huber Needle | 2023 |
What descends from it?
No later submission names this one as a predicate yet.
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 34 years and passes through 6 companies; a new generation was cleared every 5.4 years on median.
- 2 of the 7 ancestors have a recall of any class.
How does its category compare?
All FMI devicesFMI Needle, Hypodermic, Single Lumen: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 winged blood collection set is single-use, sterile, winged venipuncture needle bonded to a flexible tubing with or without a luer adapter and/or tube holder. The device is used for blood collection and/or the short-term infusion of intravenous fluids (up to 2 hours under direct clinical supervision). The blood-collection needle is designed to be covered with a safety mechanism, 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/K243806 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243806: Safety Winged Blood Collection Sets.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243806
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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