510(k) · Cleared
ClearedWinged Infusion Set, Safety Winged Infusion Set, Blood Collection Set, Blood Collection Set with Holder, Safety Blood Collection Set, Safety Blood Collection Set with Holder, Needle Holder
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Jiangsu Kangbao Medical Equipment Co., Ltd. · JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Cleared on Dec 22, 2023 as substantially equivalent to K193074 (Nsp Tech Pte, Ltd., 2020) and 1 other predicate after a 95-day review. Its family tree reaches back 6 generations to 1991.
- Decided
- Dec 22, 2023
- Review
- 95 days
- Class
- Class II
- Product code
- JKA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K912563 (1991). 15 ancestors in all, the oldest K895367 (1989). 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 backK173757 VACUETTE EVOPROTECT Safety Blood Collection / Infusion SetGreiner Bio-One Na, Inc. · 2018
- 1 generation backK214075 Safety Blood Collection / Infusion Set (with/without needle holder)…Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. · 2022
- This deviceK232881 Winged Infusion Set, Safety Winged Infusion Set, Blood Collection…Jiangsu Kangbao Medical Equipment Co., Ltd. · 2023
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 | 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 | — |
| 0 (this device) | 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 |
|---|---|---|
| 1989 | 2 | 0 |
| 1992 | 2 | 0 |
| 2001 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2013 | 1 | 0 |
| 2020 | 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 JKA? 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 JKA device
- #1 K200027 Blood Collection Needle with/without Holder…score 15.6 · 3 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 |
|---|---|---|---|
| * | K193074 | Bevel Up HolderSummary page 6…es: FMI, FPA Device Class: Class II Page 1 of 10 Primary Predicate Device: K193074 Trade Name: Bevel Up Holder Common Name: tubes, vials, systems, serum separators, blood… | 2020 |
| * | K214075 | Safety Blood Collection / Infusion Set (with/without needle holder), Blood Collection /…Summary page 6…stems, serum separators, blood collection Regulation Number: 21 CFR 862.1675 Product Code: JKA Predicate Device: K214075 Trade Name: Safety Blood Collection / Infusion Set (with/without needle holder), Bl… | 2022 |
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 32 years and passes through 7 companies; a new generation was cleared every 5.7 years on median.
- 3 of the 15 ancestors have a recall of any class.
How does its category compare?
All JKA devicesJKA Tubes, Vials, Systems, Serum Separators, Blood Collection: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · JKA
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JKA
115in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JKA
13in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JKA
6,089in 2025
MAUDE reports naming product code JKA, 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 | 4 | 281 | 3 | 73 |
| 2008 | 2 | — | 3 | 78 |
| 2009 | 2 | — | 3 | 42 |
| 2010 | 4 | 28 | 4 | 37 |
| 2011 | 0 | — | 14 | 67 |
| 2012 | 1 | — | 2 | 54 |
| 2013 | 3 | 244 | 1 | 33 |
| 2014 | 1 | — | 1 | 68 |
| 2015 | 1 | — | 6 | 41 |
| 2016 | 4 | 116 | 1 | 65 |
| 2017 | 2 | — | 2 | 2,039 |
| 2018 | 1 | — | 2 | 9,731 |
| 2019 | 6 | 181 | 9 | 6,469 |
| 2020 | 6 | 181 | 0 | 3,774 |
| 2021 | 4 | 217 | 3 | 3,610 |
| 2022 | 9 | 164 | 2 | 3,375 |
| 2023 | 17 | 189 | 2 | 4,400 |
| 2024 | 6 | 240 | 0 | 4,609 |
| 2025 | 7 | 115 | 13 | 6,089 |
| 2026 | 8 | 250 | 1 | — |
What is it indicated for?
Winged Infusion Set is indicated for 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. Safety Winged Infusion Set is indicated for 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…
Read the full statement (251 words)
Winged Infusion Set is indicated for 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.
Safety Winged Infusion Set is indicated for 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.
Blood Collection Set is indicated for venous blood collection. It is to be used by appropriately trained healthcare professionals in accordance with the instructions.
Blood Collection Set with Holder is indicated for venous blood collection. It is to be used by appropriately trained healthcare professionals in accordance with the instructions.
Safety Blood Collection Set is indicated for venous blood collection. 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.
Safety Blood Collection set with Holder is indicated for venous blood collection. 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.
Needle Holder is used for the collection of blood specimen into the blood collection tubes in routine venipuncture procedures. It is used with blood collection sets, needles and tubes. It is to be used by trained healthcare professional only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K232881 · printed Nov 6, 2026
Cite this page
510(k) Report. “K232881: Winged Infusion Set, Safety Winged Infusion Set, Blood Collection Set, Blood Collection Set with Holder, Safety Blood Collection Set, Safety Blood Collection Set with Holder, Needle Holder.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K232881
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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