510(k) Report

510(k) · Cleared

Cleared

Blood Collection Set, Blood Collection Set with Holder, Safety Blood Collection Set, Safety Blood Collection Set with Holder, Blood

K230080510(k) TraditionalCleared Jul 7, 2023177-day reviewClass II21 CFR 862.1675

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Yangzhou Medline Industry, Co., Ltd. · JKA Tubes, Vials, Systems, Serum Separators, Blood Collection

Cleared on Jul 7, 2023 as substantially equivalent to K172763 (Zhejiang Kindly Medical Devices Co., Ltd., 2018) after a 177-day review. Its family tree reaches back 3 generations to 1997. 1 later device descends from it.

Decided
Jul 7, 2023
Review
177 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.

Other ancestors, by year clearedDescendants, by year cleared 1997: 1 other ancestor2025: 1 descendant clearedK972404 · Vacutainer Brand Safety Blood Collection Assembly (Multiple) · Bd Becton Dickinson Vacutainer Systems Preanalytic · 1997 · recalledK982541 · Vacutainer Brand Eclipse Blood Collection Needle, Models# 368607 & 368608 · Becton Dickinson Vacutainer Systems · 1998 · recalledK172763 · 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 · Zhejiang Kindly Medical Devices Co., Ltd. · 20181995200020052010201520202025
Other ancestors, by generationDescendants, by generation 2 generations back: 1 other ancestor 1 generation forward: 1 descendant 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 · Zhejiang Kindly Medical Devices Co., Ltd. · 2018K982541 · Vacutainer Brand Eclipse Blood Collection Needle, Models# 368607 & 368608 · Becton Dickinson Vacutainer Systems · 1998 · recalledK972404 · Vacutainer Brand Safety Blood Collection Assembly (Multiple) · Bd Becton Dickinson Vacutainer Systems Preanalytic · 1997 · recalled0
  1. Root · 3 generations backK972404 Vacutainer Brand Safety Blood Collection Assembly (Multiple)Bd Becton Dickinson Vacutainer Systems Preanalytic · 1997 · Recalled
  2. 2 generations backK982541 Vacutainer Brand Eclipse Blood Collection Needle, Models# 368607 &…Becton Dickinson Vacutainer Systems · 1998 · Recalled
  3. 1 generation backK172763 Blood Collecting Needle, Safety Blood Collecting Needle, Blood…Zhejiang Kindly Medical Devices Co., Ltd. · 2018
  4. This deviceK230080 Blood Collection Set, Blood Collection Set with Holder, Safety Blood…Yangzhou Medline Industry, Co., Ltd. · 2023
  5. Descendant · cites it directly · 0 of its ownK250961 Blood collection tube holdersPromisemed Hangzhou Meditech Co., Ltd. · 2025

Most influential descendants

Showing 1 of 1 · See all
  • K250961Blood collection tube holdersPromisemed Hangzhou Meditech Co., Ltd. · 2025 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K972404Vacutainer Brand Safety Blood Collection Assembly (Multiple)Bd Becton Dickinson Vacutainer Systems Preanalytic19971
−2K982541Vacutainer Brand Eclipse Blood Collection Needle, Models# 368607 & 368608Becton Dickinson Vacutainer Systems19981
−1K172763Blood Collecting Needle, Safety Blood Collecting Needle, Blood Collecting…Zhejiang Kindly Medical Devices Co., Ltd.2018—
0 (this device)K230080Blood Collection Set, Blood Collection Set with Holder, Safety Blood…Yangzhou Medline Industry, Co., Ltd.2023—
+1K250961Blood collection tube holdersPromisemed Hangzhou Meditech Co., Ltd.2025—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199710

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202510
FIG. 1 — Lineage of K230080, 1997–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K200027 Blood Collection Needle with/without Holder…score 15.6 · 3 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K172763Blood Collecting Needle, Safety Blood Collecting Needle, Blood Collecting Needle with…
Summary page 6
…Classification: Class II Product Code: JKA Regulation Number: 21CFR 862.1675 5. Identification of Predicate Devices Predicate Device 510(k) Number: K172763 Product Name: Blood Collecting Needle, Safety Blood Collecting Needle, Blood Collecting Needle with Holder, Safety Blood…
Zhejiang Kindly Medical Devices Co., Ltd.2018—

Also cleared against K172763: 3 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K250961Blood collection tube holdersPromisemed Hangzhou Meditech Co., Ltd.20250

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 26 years and passes through 4 companies; a new generation was cleared every 5.1 years on median.
  • 2 of the 4 ancestors have a recall of any class.
  • Of its descendants, K250961 (Promisemed Hangzhou Meditech Co., Ltd., 2025) has gone furthest, with 0 descendants of its own.
  • 3 other devices also cite its predicate K172763.

How does its category compare?

All JKA devices

JKA 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

2007: 42008: 22009: 22010: 42012: 12013: 32014: 12015: 12016: 42017: 22018: 12019: 62020: 62021: 42022: 92023: 172024: 62025: 72026 (partial year): 8
2007high 17 (2023) · low 0 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JKA

115in 2025

2007: 281 days median2010: 28 days median2013: 244 days median2016: 116 days median2019: 181 days median2020: 181 days median2021: 217 days median2022: 164 days median2023: 189 days median2024: 240 days median2025: 115 days median2026 (partial year): 250 days median
2007high 281 (2007) · low 28 (2010)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · JKA

13in 2025

2007: 32008: 32009: 32010: 42011: 142012: 22013: 12014: 12015: 62016: 12017: 22018: 22019: 92021: 32022: 22023: 22025: 132026 (partial year): 1
2007high 14 (2011) · low 0 (2020)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JKA

6,089in 2025

2007: 732008: 782009: 422010: 372011: 672012: 542013: 332014: 682015: 412016: 652017: 2,0392018: 9,7312019: 6,4692020: 3,7742021: 3,6102022: 3,3752023: 4,4002024: 4,6092025: 6,089
2007high 9,731 (2018) · low 33 (2013)2025

MAUDE reports naming product code JKA, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20074281373
20082—378
20092—342
2010428437
20110—1467
20121—254
20133244133
20141—168
20151—641
20164116165
20172—22,039
20181—29,731
2019618196,469
2020618103,774
2021421733,610
2022916423,375
20231718924,400
2024624004,609
20257115136,089
202682501—

What is it indicated for?

The Blood Collection Set is intended to be used with vacuum blood collection tube for multiple collections of venous blood. The Blood Collection Set with Holder is intended to be used with vacuum blood collection tube for multiple collections of venous blood. The Safety Blood Collection 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…

Read the full statement (257 words)

The Blood Collection Set is intended to be used with vacuum blood collection tube for multiple collections of venous blood.

The Blood Collection Set with Holder is intended to be used with vacuum blood collection tube for multiple collections of venous blood.

The Safety Blood Collection 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 Safety Blood Collection 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.

The Blood Collection Needle is intended to be used with vacuum blood collection tube for multiple collections of venous blood.

The Blood Collection Needle with Holder is intended to be used with vacuum blood collection tube for multiple collections of venous blood.

The Safety Blood Collection 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 Safety Blood Collection 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 Luer adapter with Holder is intended to be used with vein puncture needle and vacuum blood collection tube for multiple collections of venous blood.

Indications for use as stated in the FDA summary.

Also cleared against K172763

3 other devices cite the same predicate.

  • K212019Blood Collection Needle for Single Use & Blood Collection Needle with Holder for Single Use, Safety Blood…Jiangsu Micsafe Medical Technology Co., Ltd. · 2021
  • K200027Blood Collection Needle with/without Holder, Safety Blood Collection Needle with/without Holder, Luer Access…Jiangsu Caina Medical Co.,Ltd · 2020
  • K182146Sol-M Blood Collection Needles, Sol-Care Safety Blood Collection Needles, Sol-Care Safety Blood Collection…Sol-Millennium Medical, Inc. · 2018

More from Yangzhou Medline Industry, Co., Ltd.

2 FDA decisions under this applicant name. See the company

  • K170651Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle, Sterile Disposable…Yangzhou Medline Industry, Co., Ltd. · 2017

Recent decisions in JKA

The JKA category page

  • K260857Sol-Guard™ Safety Pull Button Collection Set; Sol-Guard™ XtraThin Safety Pull-Button Blood Collection SetSol-Millennium Medical, Inc. · 2026
  • K252344BD Vacutainer® Serum Blood Collection Tubes; BD Vacutainer® Rapid Serum Tubes (RST)Becton, Dickinson and Company · 2026
  • K262215Profoject™ Safety Sliding Blood Collection SetCMT Health PTE., Ltd. · 2026
  • K252899Female Culture Device; Male Culture Device; Transfer Device; Access DeviceZhejiang Kindly Medical Device Co., Ltd. · 2026
  • K260128BD Preset™ and BD A-Line™ Arterial Blood Collection SyringesBecton, Dickinson and Company · 2026

https://510kreport.com/device/K230080 · printed Nov 5, 2026

Cite this page

510(k) Report. “K230080: Blood Collection Set, Blood Collection Set with Holder, Safety Blood Collection Set, Safety Blood Collection Set with Holder, Blood.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K230080

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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