510(k) · Cleared
ClearedBlood Collection Needle for Single Use & Blood Collection Needle with Holder for Single Use, Safety Blood Collection Needle for Single Use, Safety Blood Collection Needle with Holder for Single Use, Blood Collection Set for Single Use & Safety Blood Collection Set with Holder for Single Use, Safety Blood Collection Set for Single Use & Blood Collection Set with Holder for Single
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Jiangsu Micsafe Medical Technology Co., Ltd. · JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Cleared on Nov 4, 2021 as substantially equivalent to K172763 (Zhejiang Kindly Medical Devices Co., Ltd., 2018) after a 129-day review. Its family tree reaches back 3 generations to 1997. 1 later device descends from it.
- Decided
- Nov 4, 2021
- Review
- 129 days
- Class
- Class II
- Product code
- JKA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K972404 (1997). 4 ancestors in all, the oldest K965202 (1997). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK972404 Vacutainer Brand Safety Blood Collection Assembly (Multiple)Bd Becton Dickinson Vacutainer Systems Preanalytic · 1997 · Recalled
- 2 generations backK982541 Vacutainer Brand Eclipse Blood Collection Needle, Models# 368607 &…Becton Dickinson Vacutainer Systems · 1998 · Recalled
- 1 generation backK172763 Blood Collecting Needle, Safety Blood Collecting Needle, Blood…Zhejiang Kindly Medical Devices Co., Ltd. · 2018
- This deviceK212019 Blood Collection Needle for Single Use & Blood Collection Needle…Jiangsu Micsafe Medical Technology Co., Ltd. · 2021
- Descendant · cites it directly · 0 of its ownK220900 Safety Blood Collection Needles with/without Needle HolderAnhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. · 2022
Most influential descendants
Showing 1 of 1 · See all- K220900Safety Blood Collection Needles with/without Needle HolderAnhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K972404 | Vacutainer Brand Safety Blood Collection Assembly (Multiple) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1997 | 1 |
| −2 | K982541 | Vacutainer Brand Eclipse Blood Collection Needle, Models# 368607 & 368608 | Becton Dickinson Vacutainer Systems | 1998 | 1 |
| −1 | K172763 | Blood Collecting Needle, Safety Blood Collecting Needle, Blood Collecting… | Zhejiang Kindly Medical Devices Co., Ltd. | 2018 | — |
| 0 (this device) | K212019 | Blood Collection Needle for Single Use & Blood Collection Needle with Holder… | Jiangsu Micsafe Medical Technology Co., Ltd. | 2021 | — |
| +1 | K220900 | Safety Blood Collection Needles with/without Needle Holder | Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. | 2022 | — |
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 |
|---|---|---|
| 2022 | 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 |
|---|---|---|---|
| * | K172763 | Blood Collecting Needle, Safety Blood Collecting Needle, Blood Collecting Needle with…Summary page 6…ecting Needle with Holder, Blood Collecting Set, Safety Blood Collecting Set, Blood Collecting Set with Holder, Safety Blood Collecting Set with Holder [510(k) Number: K172763; submitted by Zhejiang kindly medical devices Co., Ltd.] Regulation Name: Blood specimen collection device… | 2018 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K220900 | Safety Blood Collection Needles with/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 24 years and passes through 4 companies; a new generation was cleared every 3.4 years on median.
- 2 of the 4 ancestors have a recall of any class.
- Of its descendants, K220900 (Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd., 2022) has gone furthest, with 0 descendants 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. 2021, 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?
(1) Blood Collection Needle for Single Use The Blood Collection Needle for Single Use is intended to be used with vacuum blood collection tube for multiple collections of venous blood. (2) Safety Blood Collection Needle for Single Use The Safety Blood Collection Needle for Single Use 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…
Read the full statement (324 words)
(1) Blood Collection Needle for Single Use
The Blood Collection Needle for Single Use is intended to be used with vacuum blood collection tube for multiple collections of venous blood.
(2) Safety Blood Collection Needle for Single Use
The Safety Blood Collection Needle for Single Use 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.
(3) Blood Collection Needle with Holder for Single Use
The Blood Collection Needle with Holder for Single Use is intended to be used with vacuum blood collection tube for multiple collections of venous blood.
(4) Safety Blood Collection Needle with Holder for Single Use
The Safety Blood Collection Needle with Holder for Single Use 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.
(5) Blood Collection Set for Single Use
The Blood Collection Set for Single Use is intended to be used with vacuum blood collection tube for multiple collections of venous blood.
(6) Safety Blood Collection Set for Single Use
The Safety Blood Collection Set for Single Use 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.
(7) Blood Collection Set with Holder for Single Use
The Blood Collection Set with Holder for Single Use is intended to be used with vacuum blood collection tube for multiple collections of venous blood.
(8) Safety Blood Collection Set with Holder for Single Use
The Safety Blood Collection Set with Holder for Single Use 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/K212019 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212019: Blood Collection Needle for Single Use & Blood Collection Needle with Holder for Single Use, Safety Blood Collection Needle for Single Use, Safety Blood Collection Needle with Holder for Single Use, Blood Collection Set for Single Use & Safety Blood Collection Set with Holder for Single Use, Safety Blood Collection Set for Single Use & Blood Collection Set with Holder for Single.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K212019
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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