510(k) · Cleared
ClearedBlood Collecting Needle, Safety Blood Collecting Needle, Blood Collecting Needle with Holder, Safety Blood Collecting Needle with Holder, Blood Collecting Set, Safety Blood Collecting Set, Blood Collecting Set with Holder, Safety Blood Collecting Set with Holder
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zhejiang Kindly Medical Devices Co., Ltd. · JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Cleared on Jun 4, 2018 as substantially equivalent to K982541 (Becton Dickinson Vacutainer Systems, 1998) and 1 other predicate after a 264-day review. Its family tree reaches back 2 generations to 1997. 13 later devices descend from it.
- Decided
- Jun 4, 2018
- Review
- 264 days
- Class
- Class II
- Product code
- JKA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K972404 (1997). 3 ancestors in all, the oldest K965202 (1997). 13 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK972404 Vacutainer Brand Safety Blood Collection Assembly (Multiple)Bd Becton Dickinson Vacutainer Systems Preanalytic · 1997 · Recalled
- 1 generation backK982541 Vacutainer Brand Eclipse Blood Collection Needle, Models# 368607 &…Becton Dickinson Vacutainer Systems · 1998 · Recalled
- This deviceK172763 Blood Collecting Needle, Safety Blood Collecting Needle, Blood…Zhejiang Kindly Medical Devices Co., Ltd. · 2018
- Descendant · cites it directly · 6 of its ownK200027 Blood Collection Needle with/without Holder, Safety Blood Collection…Jiangsu Caina Medical Co.,Ltd · 2020
- Descendant · cites it directly · 1 of its ownK230080 Blood Collection Set, Blood Collection Set with Holder, Safety Blood…Yangzhou Medline Industry, Co., Ltd. · 2023
- Descendant · 2 generations on · 1 of its ownK222478 BD Vacutainer® Luer-Lok™ Access Device, BD Vacutainer® Blood…Becton, Dickinson and Company · 2023
- Descendant · cites it directly · 1 of its ownK212019 Blood Collection Needle for Single Use & Blood Collection Needle…Jiangsu Micsafe Medical Technology Co., Ltd. · 2021
- Descendant · cites it directly · 1 of its ownK182146 Sol-M Blood Collection Needles, Sol-Care Safety Blood Collection…Sol-Millennium Medical, Inc. · 2018
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K200027Blood Collection Needle with/without Holder, Safety Blood Collection Needle with/without…Jiangsu Caina Medical Co.,Ltd · 2020 · cites it directly6descendants
- K230080Blood Collection Set, Blood Collection Set with Holder, Safety Blood Collection Set…Yangzhou Medline Industry, Co., Ltd. · 2023 · cites it directly1descendant
- K222478BD Vacutainer® Luer-Lok™ Access Device, BD Vacutainer® Blood Transfer DeviceBecton, Dickinson and Company · 2023 · 2 generations on1descendant
- K212019Blood Collection Needle for Single Use & Blood Collection Needle with Holder for Single…Jiangsu Micsafe Medical Technology Co., Ltd. · 2021 · cites it directly1descendant
- K182146Sol-M Blood Collection Needles, Sol-Care Safety Blood Collection Needles, Sol-Care…Sol-Millennium Medical, Inc. · 2018 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K972404 | Vacutainer Brand Safety Blood Collection Assembly (Multiple) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1997 | 1 |
| −1 | K982541 | Vacutainer Brand Eclipse Blood Collection Needle, Models# 368607 & 368608 | Becton Dickinson Vacutainer Systems | 1998 | 1 |
| 0 (this device) | K172763 | Blood Collecting Needle, Safety Blood Collecting Needle, Blood Collecting… | Zhejiang Kindly Medical Devices Co., Ltd. | 2018 | — |
| +1 | K200027 | Blood Collection Needle with/without Holder, Safety Blood Collection Needle… | Jiangsu Caina Medical Co.,Ltd | 2020 | — |
| +1 | K230080 | Blood Collection Set, Blood Collection Set with Holder, Safety Blood… | Yangzhou Medline Industry, Co., Ltd. | 2023 | — |
| +2 | K222478 | BD Vacutainer® Luer-Lok™ Access Device, BD Vacutainer® Blood Transfer Device | Becton, Dickinson and Company | 2023 | — |
| +1 | K212019 | Blood Collection Needle for Single Use & Blood Collection Needle with Holder… | Jiangsu Micsafe Medical Technology Co., Ltd. | 2021 | — |
| +1 | K182146 | Sol-M Blood Collection Needles, Sol-Care Safety Blood Collection Needles… | Sol-Millennium Medical, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 3 | 0 |
| 2023 | 3 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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 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 |
|---|---|---|---|
| * | K982541 | Vacutainer Brand Eclipse Blood Collection Needle, Models# 368607 & 368608Summary page 10…E2 510(k) Summary 5. Identification of Predicate Devices Predicate Device 1 510(k) Number: K982541 Product Name: VACUTAINER® Brand ECLIPSETM Blood Collection Needle Predicate Device 2 510(k) Number: K965202… | 1998 |
| * | K965202 | Vacutainer Brand Safety-Lok Blood Collection SetSummary page 10…Predicate Device 1 510(k) Number: K982541 Product Name: VACUTAINER® Brand ECLIPSETM Blood Collection Needle Predicate Device 2 510(k) Number: K965202 Product Name: VACUTAINER® Brand Safety-Lok Blood Collection Set… | 1997 |
What descends from it? (13)
See all 134 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K200027 | Blood Collection Needle with/without Holder, Safety Blood Collection Needle with/without… | 2020 | 6 |
| K230080 | Blood Collection Set, Blood Collection Set with Holder, Safety Blood Collection Set… | 2023 | 1 |
| K212019 | Blood Collection Needle for Single Use & Blood Collection Needle with Holder for Single… | 2021 | 1 |
| K182146 | Sol-M Blood Collection Needles, Sol-Care Safety Blood Collection Needles, Sol-Care… | 2018 | 1 |
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 21 years and passes through 3 companies; a new generation was cleared every 19.6 years on median.
- 2 of the 3 ancestors have a recall of any class.
- Of its descendants, K200027 (Jiangsu Caina Medical Co.,Ltd, 2020) has gone furthest, with 6 descendants of its own.
- 7 other devices also cite its predicate K982541.
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. 2018, 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 Collecting Needle is intended to be used with vacuum blood collection tube for multiple collections of venous blood. The Safety Blood Collecting Needle is intended to be used with vacuum blood collection tube for multiple collections of venous blood. The safety shield is intended to aid in the protection against accidental needle stick injury. The Blood Collecting Needle with Holder is intended to be used with vacuum blood collection tube for…
Read the full statement (232 words)
The Blood Collecting Needle is intended to be used with vacuum blood collection tube for multiple collections of venous blood.
The Safety Blood Collecting Needle is intended to be used with vacuum blood collection tube for multiple collections of venous blood. The safety shield is intended to aid in the protection against accidental needle stick injury.
The Blood Collecting Needle with Holder is intended to be used with vacuum blood collection tube for multiple collections of venous blood.
The Safety Blood Collecting Needle with Holder is intended to be used with vacuum blood collection tube for multiple collections of venous blood. The safety shield is intended to aid in the protection against accidental needle stick injury.
The Blood Collecting Set is intended to be used with vacuum blood collection tube for multiple collections of venous blood.
The Safety Blood Collecting Set is intended to be used with vacuum blood collection tube for multiple collections of venous blood. The safety shield is intended to aid in the protection against accidental needle stick injury.
The Blood Collecting Set with Holder is intended to be used with vacuum blood collection tube for multiple collections of venous blood.
The Safety Blood Collecting Set with Holder is intended to be used with vacuum blood collection tube for multiple collections of venous blood. The safety shield is intended to aid in the protection against accidental needle stick injury.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K172763 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172763: Blood Collecting Needle, Safety Blood Collecting Needle, Blood Collecting Needle with Holder, Safety Blood Collecting Needle with Holder, Blood Collecting Set, Safety Blood Collecting Set, Blood Collecting Set with Holder, Safety Blood Collecting Set with Holder.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172763
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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