510(k) Report

510(k) · Cleared

Recalled · 2007

Vacutainer Brand Safety-Lok Blood Collection Set Model Multiple, Vacutainer Brand Blood Collection Set

K980414510(k) TraditionalCleared Mar 3, 199828-day reviewClass II21 CFR 862.1675Recalls 1

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 Mar 3, 1998 as substantially equivalent to K970259 (Becton Dickinson Vascular Access, Inc., 1997) after a 28-day review. Its family tree reaches back 1 generation to 1997. 47 later devices descend from it. It has been recalled once.

Decided
Mar 3, 1998
Review
28 days
Class
Class II
Product code
JKA
Recalls
1
Predicates
1

Its longest line of descent runs back 1 generation to K970259 (1997). 47 later devices descend from it, 12 citing it directly.

Descendants, by year cleared 2001: 2 descendants cleared2010: 4 descendants cleared1999: 1 descendant cleared2003: 3 descendants cleared2024: 2 descendants cleared2026: 2 descendants cleared2016: 3 descendants cleared2017: 1 descendant cleared2022: 5 descendants cleared2002: 1 descendant cleared2013: 1 descendant cleared2020: 4 descendants cleared2011: 1 descendant cleared2023: 6 descendants cleared2007: 1 descendant cleared2018: 1 descendant cleared2019: 2 descendants cleared2005: 1 descendant cleared2015: 1 descendant cleared2014: 3 descendants cleared2025: 2 descendants clearedK970259 · E-Z Set Infusion Set/Saf-T E-Z Set Infusion Set · Becton Dickinson Vascular Access, Inc. · 19971995200020052010201520202025
Descendants, by generation 1 generation forward: 12 descendants2 generations forward: 14 descendants3 generations forward: 15 descendants4 generations forward: 6 descendants K970259 · E-Z Set Infusion Set/Saf-T E-Z Set Infusion Set · Becton Dickinson Vascular Access, Inc. · 19970
  1. Root · 1 generation backK970259 E-Z Set Infusion Set/Saf-T E-Z Set Infusion SetBecton Dickinson Vascular Access, Inc. · 1997
  2. This deviceK980414 Vacutainer Brand Safety-Lok Blood Collection Set Model Multiple…Bd Becton Dickinson Vacutainer Systems Preanalytic · 1998
  3. Descendant · cites it directly · 23 of its ownK011984 BD Vacutainer Push Button Blood Colection SetBecton, Dickinson & CO · 2001 · Recalled
  4. Descendant · 2 generations on · 18 of its ownK022875 Modification to BD Vacutainer Push Button Blood Collection SetBecton, Dickinson & CO · 2002
  5. Descendant · cites it directly · 17 of its ownK030573 BD Vacutainer Push Button Blood Collection Set, Models 367338…Bd Vacutainer Systems Preanalyical Solutions · 2003 · Recalled
  6. Descendant · 2 generations on · 6 of its ownK153309 BD Vacutainer UltraTouch Push Button Blood Collection SetBecton, Dickinson and Company · 2016
  7. Descendant · 2 generations on · 5 of its ownK192247 Steripath Gen2 Blood Collection SystemMagnolia Medical Technologies, Inc. · 2020 · Recalled

Showing 5 of 47 descendants. See all descendants

Descendants cleared per year

1999: 12001: 22002: 12003: 32005: 12007: 12010: 42011: 12013: 12014: 32015: 12016: 32017: 12018: 12019: 22020: 42022: 52023: 62024: 22025: 22026: 2
1999high 6 (2023) · low 0 (2000)2026

Most influential descendants

Showing 5 of 47 · See all
  • K011984BD Vacutainer Push Button Blood Colection SetBecton, Dickinson & CO · 2001 · cites it directly23descendants
  • K022875Modification to BD Vacutainer Push Button Blood Collection SetBecton, Dickinson & CO · 2002 · 2 generations on18descendants
  • K030573BD Vacutainer Push Button Blood Collection Set, Models 367338, 367344, 367336, 367342…Bd Vacutainer Systems Preanalyical Solutions · 2003 · cites it directly17descendants
  • K153309BD Vacutainer UltraTouch Push Button Blood Collection SetBecton, Dickinson and Company · 2016 · 2 generations on6descendants
  • K192247Steripath Gen2 Blood Collection SystemMagnolia Medical Technologies, Inc. · 2020 · 2 generations on5descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K970259E-Z Set Infusion Set/Saf-T E-Z Set Infusion SetBecton Dickinson Vascular Access, Inc.1997—
0 (this device)K980414Vacutainer Brand Safety-Lok Blood Collection Set Model Multiple, Vacutainer…Bd Becton Dickinson Vacutainer Systems Preanalytic1998—
+1K011984BD Vacutainer Push Button Blood Colection SetBecton, Dickinson & CO20017
+2K022875Modification to BD Vacutainer Push Button Blood Collection SetBecton, Dickinson & CO2002—
+1K030573BD Vacutainer Push Button Blood Collection Set, Models 367338, 367344, 367336…Bd Vacutainer Systems Preanalyical Solutions20035
+2K153309BD Vacutainer UltraTouch Push Button Blood Collection SetBecton, Dickinson and Company2016—
+2K192247Steripath Gen2 Blood Collection SystemMagnolia Medical Technologies, Inc.20202

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199910
200120
200210
200330
200510
200710
201040
201110
201310
201430
201510
201630
201710
201810
201920
202040
202250
202360
202420
202520
202620
FIG. 1 — Lineage of K980414, 1997–2026Source: 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
*K970259E-Z Set Infusion Set/Saf-T E-Z Set Infusion Set
Summary page 3
…is supported by a comparison of device components, intended use and function. E-Z Set® Intravascular Administration Set Becton Dickinson Infusion Therapy systems RS K970259 Becton Dickinson Infusion Therapy systems Safety E-Z Set® Intravascular Administration Set K970259 ' | April 8, 1997 » . o f…
Becton Dickinson Vascular Access, Inc.1997—

What descends from it? (47)

See all 47

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

NumberDeviceApplicantDecidedDescendants
K011984BD Vacutainer Push Button Blood Colection SetBecton, Dickinson & CO200123
K030573BD Vacutainer Push Button Blood Collection Set, Models 367338, 367344, 367336, 367342…Bd Vacutainer Systems Preanalyical Solutions200317
K033350BD Vacutainer Safety-Lok Administration Set with FilterBecton, Dickinson & CO20035
K013164Surshield Safety Winged Blood Collection SetTerumo Medical Corp.20014
K162233Kurin Blood Culture Collection SetPathway, LLC20162
K163073Sol-Care Safety Blood Collection Needle with and without Pre-Attached HolderSol-Millennium Medical, Inc.20171
K102994K-Shield Arterial Venous Fistula Set with Antineedle Stick ProtectorKawasumi Laboratories, Inc.20101
K252506BD Vacutainer® Safety-Lok™ Blood Collection Set; BD Vacutainer® Safety-Lok™ Blood…Becton, Dickinson and Company20260
K232781Safety Sliding Blood Collection SetJiangsu Caina Medical Co.,Ltd20240
K153388IMPROSAFE Blood Collection Set with Pre-attached Holder, IMPROVACUTER Blood Collection…Guangzhou Improve Medical Instruments Co., Ltd.20160

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Mar 20, 2007Not classifiedZ-0777-2007OtherThe BD Vacutainer Safety-Lok Blood Collection Set with Preattached Holder has a problem where the non-patient needle (in the holder) may become separated from the hub and remain the stopper of an evacuated blood collection tube.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has no recall.
  • Of its descendants, K011984 (Becton, Dickinson & CO, 2001) has gone furthest, with 23 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?

THE VACUTAINER® BRAND BLOOD COLLECTION SETS AND SAFETY-LOK™ BLOOD COLLECTION SET IS A WINGED BLOOD COLLECTION NEEDLE AND FLEXIBLE TUBING FOR VENIPUNCTURE TO COLLECT BLOOD SPECIMENS FROM PATIENTS OR MONITORING BLOOD PRESSURE. THE SAFETY-LOK™ BLOOD COLLECTION SET ALSO CONTAINS A NEEDLE SAFETY SHIELD WHICH MINIMIZES THE POSSIBILITY OF NEEDLESTICKS IF MANUALLY ACTIVATED FOLLOWING BLOOD COLLECTION. THE VACUTAINER® BRAND BLOOD COLLECTION SETS AND SAFETY-LOK™…

Read the full statement (120 words)

THE VACUTAINER® BRAND BLOOD COLLECTION SETS AND SAFETY-LOK™ BLOOD COLLECTION SET IS A WINGED BLOOD COLLECTION NEEDLE AND FLEXIBLE TUBING FOR VENIPUNCTURE TO COLLECT BLOOD SPECIMENS FROM PATIENTS OR MONITORING BLOOD PRESSURE. THE SAFETY-LOK™ BLOOD COLLECTION SET ALSO CONTAINS A NEEDLE SAFETY SHIELD WHICH MINIMIZES THE POSSIBILITY OF NEEDLESTICKS IF MANUALLY ACTIVATED FOLLOWING BLOOD COLLECTION. THE VACUTAINER® BRAND BLOOD COLLECTION SETS AND SAFETY-LOK™ BLOOD COLLECTION SET IS ALSO RECOMMENDED FOR USE IN PATIENTS WITH SMALL VEINS.

THE VACUTAINER® BRAND BLOOD COLLECTION SETS AND SAFETY-LOK™ BLOOD COLLECTION SET IS ALSO INDICATED FOR THE INTRAVENOUS ADMINISTRATION OF FLUIDS AND MAY BE USED FOR ANY PATIENT POPULATION WITH CONSIDERATION GIVEN TO PATIENT SIZE, APPROPRIATENESS FOR THE SOLUTION BEING INFUSED AND DURATION OF THERAPY.

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/K980414 · printed Nov 4, 2026

Cite this page

510(k) Report. “K980414: Vacutainer Brand Safety-Lok Blood Collection Set Model Multiple, Vacutainer Brand 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/K980414

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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