510(k) · Cleared
ClearedFemale Culture Device; Male Culture Device; Transfer Device; Access Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zhejiang Kindly Medical Device Co., Ltd. · JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Cleared on Jun 2, 2026 as substantially equivalent to K222478 (Becton, Dickinson and Company, 2023) after a 264-day review. Its family tree reaches back 5 generations to 1993.
- Decided
- Jun 2, 2026
- Review
- 264 days
- Class
- Class II
- Product code
- JKA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K931367 (1993). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK931367 Vacutainer Brand Luer AdapterBd Becton Dickinson Vacutainer Systems Preanalytic · 1993
- 4 generations backK983490 Terumo Venoject,Luer AdapterTerumo Corp. · 1998
- 3 generations backK991088 Vacutainer Brand Multiple Sample Luer Adapter, Blood Collection Sets…Becton Dickinson Vacutainer Systems · 1999 · Recalled
- 2 generations backK200027 Blood Collection Needle with/without Holder, Safety Blood Collection…Jiangsu Caina Medical Co.,Ltd · 2020
- 1 generation backK222478 BD Vacutainer® Luer-Lok™ Access Device, BD Vacutainer® Blood…Becton, Dickinson and Company · 2023
- This deviceK252899 Female Culture Device; Male Culture Device; Transfer Device; Access…Zhejiang Kindly Medical Device Co., Ltd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K931367 | Vacutainer Brand Luer Adapter | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1993 | — |
| −4 | K983490 | Terumo Venoject,Luer Adapter | Terumo Corp. | 1998 | — |
| −3 | K991088 | Vacutainer Brand Multiple Sample Luer Adapter, Blood Collection Sets and… | Becton Dickinson Vacutainer Systems | 1999 | 4 |
| −2 | K200027 | Blood Collection Needle with/without Holder, Safety Blood Collection Needle… | Jiangsu Caina Medical Co.,Ltd | 2020 | — |
| −1 | K222478 | BD Vacutainer® Luer-Lok™ Access Device, BD Vacutainer® Blood Transfer Device | Becton, Dickinson and Company | 2023 | — |
| 0 (this device) | K252899 | Female Culture Device; Male Culture Device; Transfer Device; Access Device | Zhejiang Kindly Medical Device Co., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 2018 | 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? (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 |
|---|---|---|---|
| * | K222478 | BD Vacutainer® Luer-Lok™ Access Device, BD Vacutainer® Blood Transfer DeviceSummary page 5…ials, Systems, Serum Separators, Blood Collection Regulatory Class: II Product Code: JKA Review Panel: Clinical Chemistry 4. Predicate device 510(k) number: K222478 Trade name: BD Vacutainer® Luer-Lok™ Access Device, BD Vacutainer® Blood Transfer Device Regulation Number: 21 CFR 862.1… | 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 33 years and passes through 6 companies; a new generation was cleared every 3.2 years on median.
- 3 of the 9 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. 2026, 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?
Female Culture Device is used for the collection of blood from a catheter hub or luer connector via vacuum-assisted collection device such as vacuum blood collection tube, sampling bottle. This device may also be used with a collection set with a male Luer to collect blood cultures. This device is to be used by properly trained healthcare professionals only in accordance with these instructions. Male Culture Device is used for the collection of blood…
Read the full statement (254 words)
Female Culture Device is used for the collection of blood from a catheter hub or luer connector via vacuum-assisted collection device such as vacuum blood collection tube, sampling bottle. This device may also be used with a collection set with a male Luer to collect blood cultures. This device is to be used by properly trained healthcare professionals only in accordance with these instructions.
Male Culture Device is used for the collection of blood from a catheter hub or luer connector via vacuum-assisted collection device such as vacuum blood collection tube, sampling bottle. This device may also be used with a collection set with a female Luer to collect blood cultures. This device is to be used by properly trained healthcare professionals only in accordance with these instructions.
Transfer Device is used for the collection of blood from a catheter hub or luer connector via vacuum-assisted collection device such as vacuum blood collection tube, sampling bottle. This device may also be used with a collection set with a male Luer to collect blood cultures. This device is to be used by properly trained healthcare professionals only in accordance with these instructions.
Access Device is used for the collection of blood from a catheter hub or luer connector via vacuum-assisted collection device such as vacuum blood collection tube, sampling bottle. This device may also be used with a collection set with a female Luer to collect blood cultures. This device is to be used by properly trained healthcare professionals only in accordance with these instructions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252899 · printed Nov 6, 2026
Cite this page
510(k) Report. “K252899: Female Culture Device; Male Culture Device; Transfer Device; Access Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K252899
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026