510(k) Report

510(k) · Cleared

Cleared

Vacutainer Brand Safety-Lok Blood Collection Set

K965202510(k) TraditionalCleared Feb 10, 199746-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

Bd Becton Dickinson Vacutainer Systems Preanalytic · JKA Tubes, Vials, Systems, Serum Separators, Blood Collection

Cleared on Feb 10, 1997 after a 46-day review. The FDA summary names its predicate without a number. 139 later devices descend from it.

Decided
Feb 10, 1997
Review
46 days
Class
Class II
Product code
JKA
Recalls
None
Predicates
0

139 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2001: 1 descendant cleared2002: 2 descendants cleared2018: 5 descendants cleared2022: 23 descendants cleared2010: 3 descendants cleared2007: 2 descendants cleared2017: 5 descendants cleared2025: 10 descendants cleared2016: 5 descendants cleared2014: 1 descendant cleared2021: 15 descendants cleared2023: 26 descendants cleared2020: 8 descendants cleared2003: 1 descendant cleared2011: 5 descendants cleared2013: 5 descendants cleared2026: 5 descendants cleared2008: 1 descendant cleared2009: 1 descendant cleared2019: 4 descendants cleared2024: 8 descendants cleared2015: 2 descendants cleared2012: 1 descendant cleared1995200020052010201520202025
  1. This deviceK965202 Vacutainer Brand Safety-Lok Blood Collection SetBd Becton Dickinson Vacutainer Systems Preanalytic · 1997
  2. Descendant · cites it directly · 100 of its ownK021475 BD Single Lumen Needle, Syringe and Blood Collection SetBd · 2002 · Recalled
  3. Descendant · 2 generations on · 91 of its ownK070440 BD Hypoint NeedleBecton, Dickinson & CO · 2007
  4. Descendant · 3 generations on · 78 of its ownK072739 Jierui Syringes and NeedlesShandong Weigao Group Medical Polymer Co., Ltd. · 2008
  5. Descendant · 4 generations on · 36 of its ownK110421 Disposable Insulin SyringeWenzhou Wuzhou Import & Export Co., Ltd. · 2011
  6. Descendant · 3 generations on · 31 of its ownK112057 KDL Syringes and NeedleShanghai Kindly Enterprise Dev. Group Co., · 2011

Showing 5 of 139 descendants. See all descendants

Descendants cleared per year

2001: 12002: 22003: 12007: 22008: 12009: 12010: 32011: 52012: 12013: 52014: 12015: 22016: 52017: 52018: 52019: 42020: 82021: 152022: 232023: 262024: 82025: 102026: 5
2001high 26 (2023) · low 0 (2004)2026

Most influential descendants

Showing 5 of 139 · See all
  • K021475BD Single Lumen Needle, Syringe and Blood Collection SetBd · 2002 · cites it directly100descendants
  • K070440BD Hypoint NeedleBecton, Dickinson & CO · 2007 · 2 generations on91descendants
  • K072739Jierui Syringes and NeedlesShandong Weigao Group Medical Polymer Co., Ltd. · 2008 · 3 generations on78descendants
  • K110421Disposable Insulin SyringeWenzhou Wuzhou Import & Export Co., Ltd. · 2011 · 4 generations on36descendants
  • K112057KDL Syringes and NeedleShanghai Kindly Enterprise Dev. Group Co., · 2011 · 3 generations on31descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K965202Vacutainer Brand Safety-Lok Blood Collection SetBd Becton Dickinson Vacutainer Systems Preanalytic1997—
+1K021475BD Single Lumen Needle, Syringe and Blood Collection SetBd20023
+2K070440BD Hypoint NeedleBecton, Dickinson & CO2007—
+3K072739Jierui Syringes and NeedlesShandong Weigao Group Medical Polymer Co., Ltd.2008—
+4K110421Disposable Insulin SyringeWenzhou Wuzhou Import & Export Co., Ltd.2011—
+3K112057KDL Syringes and NeedleShanghai Kindly Enterprise Dev. Group Co.,2011—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200110
200220
200310
200720
200810
200910
201030
201150
201210
201350
201410
201520
201650
201750
201850
201940
202080
2021150
2022230
2023260
202480
2025100
202650
FIG. 1 — Lineage of K965202, 1997–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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
*—VACUTAINER® Brand Safety-Lok™ Blood Collection Set
Named without a submission number
—

What descends from it? (139)

See all 139

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K021475BD Single Lumen Needle, Syringe and Blood Collection SetBd2002100
K011984BD Vacutainer Push Button Blood Colection SetBecton, Dickinson & CO200123
K172763Blood Collecting Needle, Safety Blood Collecting Needle, Blood Collecting Needle with…Zhejiang Kindly Medical Devices Co., Ltd.201813

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?

  • Of its descendants, K021475 (Bd, 2002) has gone furthest, with 100 descendants of its own.

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.

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?

A needle and attached tubing for venipuncture and the collection of blood specimens from patients. Includes a safety shield to minimize the possibility of needlesticks.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Bd Becton Dickinson Vacutainer Systems…

656 FDA decisions under this applicant name. See the company

  • K003062Bactec Mgit 960 Sir KitsBd Becton Dickinson Vacutainer Systems Preanalytic · 2001
  • K0035530.9% Sodium Chloride Injection, Usp BD Pre-Filled Flush SyringeBd Becton Dickinson Vacutainer Systems Preanalytic · 2001
  • K003461BD Vacutainer Passive Shielding Blood Collection NeedleBd Becton Dickinson Vacutainer Systems Preanalytic · 2001
  • K002938B-D Ultra-Fine Iii Pen Needle; Model 31G X 3/16Bd Becton Dickinson Vacutainer Systems Preanalytic · 2000
  • K001364BD Directigen Flu a+BBd Becton Dickinson Vacutainer Systems Preanalytic · 2000

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/K965202 · printed Nov 4, 2026

Cite this page

510(k) Report. “K965202: Vacutainer Brand Safety-Lok Blood Collection Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K965202

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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