510(k) · Cleared
ClearedBlood Collection Needle with/without Holder, Safety Blood Collection Needle with/without Holder, Luer Access Device-holder with Preattached Multiple Sample Adapter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Jiangsu Caina Medical Co.,Ltd · JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Cleared on Sep 9, 2020 as substantially equivalent to K172763 (Zhejiang Kindly Medical Devices Co., Ltd., 2018) and 1 other predicate after a 247-day review. Its family tree reaches back 3 generations to 1993. 6 later devices descend from it.
- Decided
- Sep 9, 2020
- Review
- 247 days
- Class
- Class II
- Product code
- JKA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K931367 (1993). 7 ancestors in all. 6 later devices descend from it, 5 citing it directly.
- Root · 3 generations backK931367 Vacutainer Brand Luer AdapterBd Becton Dickinson Vacutainer Systems Preanalytic · 1993
- 2 generations backK983490 Terumo Venoject,Luer AdapterTerumo Corp. · 1998
- 1 generation backK991088 Vacutainer Brand Multiple Sample Luer Adapter, Blood Collection Sets…Becton Dickinson Vacutainer Systems · 1999 · Recalled
- This deviceK200027 Blood Collection Needle with/without Holder, Safety Blood Collection…Jiangsu Caina Medical Co.,Ltd · 2020
- Descendant · cites it directly · 1 of its ownK222478 BD Vacutainer® Luer-Lok™ Access Device, BD Vacutainer® Blood…Becton, Dickinson and Company · 2023
- Descendant · 2 generations on · 0 of its ownK252899 Female Culture Device; Male Culture Device; Transfer Device; Access…Zhejiang Kindly Medical Device Co., Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK233979 VACUETTE® QUICKSHIELD Complete (Plus)Greiner Bio-One North America, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK223323 Blood Collection Needle (with/without Needle Holder)Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK213690 Eclipse Blood Collection SetEclipse Medcorp, LLC · 2022
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K222478BD Vacutainer® Luer-Lok™ Access Device, BD Vacutainer® Blood Transfer DeviceBecton, Dickinson and Company · 2023 · cites it directly1descendant
- K252899Female Culture Device; Male Culture Device; Transfer Device; Access DeviceZhejiang Kindly Medical Device Co., Ltd. · 2026 · 2 generations on0descendants
- K233979VACUETTE® QUICKSHIELD Complete (Plus)Greiner Bio-One North America, Inc. · 2024 · cites it directly0descendants
- K223323Blood Collection Needle (with/without Needle Holder)Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. · 2023 · cites it directly0descendants
- K213690Eclipse Blood Collection SetEclipse Medcorp, LLC · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K931367 | Vacutainer Brand Luer Adapter | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1993 | — |
| −2 | K983490 | Terumo Venoject,Luer Adapter | Terumo Corp. | 1998 | — |
| −1 | K991088 | Vacutainer Brand Multiple Sample Luer Adapter, Blood Collection Sets and… | Becton Dickinson Vacutainer Systems | 1999 | 4 |
| 0 (this device) | 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 | — |
| +2 | K252899 | Female Culture Device; Male Culture Device; Transfer Device; Access Device | Zhejiang Kindly Medical Device Co., Ltd. | 2026 | — |
| +1 | K233979 | VACUETTE® QUICKSHIELD Complete (Plus) | Greiner Bio-One North America, Inc. | 2024 | — |
| +1 | K223323 | Blood Collection Needle (with/without Needle Holder) | Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. | 2023 | — |
| +1 | K213690 | Eclipse Blood Collection Set | Eclipse Medcorp, LLC | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 2018 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2026 | 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 K230865 PIVO™ Pro Needle-free Blood Collection Devicescore 14.2 · 8 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 |
|---|---|---|---|
| * | K172763 | Blood Collecting Needle, Safety Blood Collecting Needle, Blood Collecting Needle with…Summary page 6…nect with medical vacuum tubes and transfer fluids. 5. Identification of Predicate Devices Predicate Device 1 510(k) Number: K172763 Product Name: Blood Collecting Needle, Safety Blood Collecting Needle, Blood Collecting Needle with Holder,… | 2018 |
| * | K991088 | Vacutainer Brand Multiple Sample Luer Adapter, Blood Collection Sets and Safety-Lok…Summary page 6…r, Safety Blood Collecting Set with Holder Regulation number: 862.1675 Product Code: JKA Predicate Device 2 510(k) Number: K991088 ＠ Product Name: VACUTAINER Brand Multiple Sample Luer Adapter Regulation… | 1999 |
| † | K172938 | Disposable Sterile Needle | 2018 |
What descends from it? (6)
5 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K222478 | BD Vacutainer® Luer-Lok™ Access Device, BD Vacutainer® Blood Transfer Device | 2023 | 1 |
| K233979 | VACUETTE® QUICKSHIELD Complete (Plus) | 2024 | 0 |
| K223323 | Blood Collection Needle (with/without Needle Holder) | 2023 | 0 |
| K213690 | Eclipse Blood Collection Set | 2022 | 0 |
| K222141 | Safety Blood Collection Needle (Without Needle Holder) | 2022 | 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 27 years and passes through 4 companies; a new generation was cleared every 5.6 years on median.
- 3 of the 7 ancestors have a recall of any class.
- Of its descendants, K222478 (Becton, Dickinson and Company, 2023) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K172763.
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. 2020, 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?
The Blood Collection Needle with/without holder is intended to be used with vacuum blood collection tube for the collection of venous blood.
The Safety Blood Collection Needle with/without holder is intended to be used with vacuum blood collection tube for the collection of venous blood. The safety shield is intended to aid in the protection against accidental needle stick injury.
The Luer access device- holder with preattached multiple sample adapter is a sterile, non-invasive device used to connect devices with male or female luer connectors to blood collection tubes for the collection of blood.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200027 · printed Nov 3, 2026
Cite this page
510(k) Report. “K200027: Blood Collection Needle with/without Holder, Safety Blood Collection Needle with/without Holder, Luer Access Device-holder with Preattached Multiple Sample Adapter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K200027
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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