510(k) Report

510(k) · Cleared

Cleared

Modification to BD Vacutainer Push Button Blood Collection Set

K022875510(k) SpecialCleared Sep 11, 200212-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

Becton, Dickinson & CO · JKA Tubes, Vials, Systems, Serum Separators, Blood Collection

Cleared on Sep 11, 2002 as substantially equivalent to K011984 (Becton, Dickinson & CO, 2001) after a 12-day review. Its family tree reaches back 3 generations to 1997. 18 later devices descend from it.

Decided
Sep 11, 2002
Review
12 days
Class
Class II
Product code
JKA
Recalls
None
Predicates
1

Its longest line of descent runs back 3 generations to K970259 (1997). 6 ancestors in all, the oldest K921636 (1992). 18 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1997: 1 other ancestor1993: 1 other ancestor1992: 1 other ancestor2003: 1 descendant cleared2013: 1 descendant cleared2016: 1 descendant cleared2020: 2 descendants cleared2011: 1 descendant cleared2023: 5 descendants cleared2022: 4 descendants cleared2024: 1 descendant cleared2025: 2 descendants clearedK970259 · E-Z Set Infusion Set/Saf-T E-Z Set Infusion Set · Becton Dickinson Vascular Access, Inc. · 1997K980414 · Vacutainer Brand Safety-Lok Blood Collection Set Model Multiple, Vacutainer Brand Blood Collection Set · Bd Becton Dickinson Vacutainer Systems Preanalytic · 1998 · recalledK011984 · BD Vacutainer Push Button Blood Colection Set · Becton, Dickinson & CO · 2001 · recalled1990200020102020
Other ancestors, by generationDescendants, by generation 2 generations back: 3 other ancestors 1 generation forward: 1 descendant2 generations forward: 5 descendants3 generations forward: 7 descendants4 generations forward: 5 descendants K011984 · BD Vacutainer Push Button Blood Colection Set · Becton, Dickinson & CO · 2001 · recalledK980414 · Vacutainer Brand Safety-Lok Blood Collection Set Model Multiple, Vacutainer Brand Blood Collection Set · Bd Becton Dickinson Vacutainer Systems Preanalytic · 1998 · recalledK970259 · E-Z Set Infusion Set/Saf-T E-Z Set Infusion Set · Becton Dickinson Vascular Access, Inc. · 19970
  1. Root · 3 generations backK970259 E-Z Set Infusion Set/Saf-T E-Z Set Infusion SetBecton Dickinson Vascular Access, Inc. · 1997
  2. 2 generations backK980414 Vacutainer Brand Safety-Lok Blood Collection Set Model Multiple…Bd Becton Dickinson Vacutainer Systems Preanalytic · 1998 · Recalled
  3. 1 generation backK011984 BD Vacutainer Push Button Blood Colection SetBecton, Dickinson & CO · 2001 · Recalled
  4. This deviceK022875 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
  8. Descendant · 3 generations on · 2 of its ownK213718 SOL-GUARD Safety Pull Button Collection SetSol-Millennium Medical, Inc. · 2022
  9. Descendant · 3 generations on · 2 of its ownK200661 Steripath Micro Blood Collection SystemMagnolia Medical Technologies, Inc. · 2020

Showing 5 of 18 descendants. See all descendants

Descendants cleared per year

2003: 12011: 12013: 12016: 12020: 22022: 42023: 52024: 12025: 2
2003high 5 (2023) · low 0 (2004)2026

Most influential descendants

Showing 5 of 18 · See all
  • 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
  • K213718SOL-GUARD Safety Pull Button Collection SetSol-Millennium Medical, Inc. · 2022 · 3 generations on2descendants
  • K200661Steripath Micro Blood Collection SystemMagnolia Medical Technologies, Inc. · 2020 · 3 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K970259E-Z Set Infusion Set/Saf-T E-Z Set Infusion SetBecton Dickinson Vascular Access, Inc.1997—
−2K980414Vacutainer Brand Safety-Lok Blood Collection Set Model Multiple, Vacutainer…Bd Becton Dickinson Vacutainer Systems Preanalytic19981
−1K011984BD Vacutainer Push Button Blood Colection SetBecton, Dickinson & CO20017
0 (this device)K022875Modification 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
+3K213718SOL-GUARD Safety Pull Button Collection SetSol-Millennium Medical, Inc.2022—
+3K200661Steripath Micro Blood Collection SystemMagnolia Medical Technologies, Inc.2020—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199210
199310
199710

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
201110
201310
201610
202020
202240
202350
202410
202520
FIG. 1 — Lineage of K022875, 1997–2025Source: 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
*K011984BD Vacutainer Push Button Blood Colection SetBecton, Dickinson & CO20017

Also cleared against K011984: 2 other devices →

What descends from it? (18)

See all 18

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

NumberDeviceApplicantDecidedDescendants
K030573BD Vacutainer Push Button Blood Collection Set, Models 367338, 367344, 367336, 367342…Bd Vacutainer Systems Preanalyical Solutions200317

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 5 years and passes through 3 companies; a new generation was cleared every 1.0 years on median.
  • 2 of the 6 ancestors have a recall of any class.
  • Of its descendants, K030573 (Bd Vacutainer Systems Preanalyical Solutions, 2003) has gone furthest, with 17 descendants of its own.
  • 2 other devices also cite its predicate K011984.

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 BD Vacutainer™ Push Button Blood Collection Set is a sterile, multiple-sample, single-use winged blood collection set intended for venipuncture to obtain blood specimens from patients. The recommended use of the device is to activate the needle prior to removal from the venipuncture site. The retraction of the intravenous (IV) end of the needle aids in the prevention of needlestick injury.

Indications for use as stated in the FDA summary.

Also cleared against K011984

2 other devices cite the same predicate.

  • K220799K-SHIELD ZenSb-Kawasumi Laboratories, Inc. · 2022
  • K102010Vacuette Premium Safety Blood Collection SetMedpro Safety Products, Inc. · 2010

More from Becton, Dickinson & CO

190 FDA decisions under this applicant name. See the company

  • K160164BD Veritor System for Rapid Detection of Flu A + B Labratory KitBecton, Dickinson & CO · 2016
  • K160161BD Veritor System for Rapid Detection of Flu A + B CLIA waived kitBecton, Dickinson & CO · 2016
  • K141474Becton Dickinson Intelliport SystemBecton, Dickinson & CO · 20141 recall
  • K140446BD Probetec Chlamydia Trachomatis (CT) QX Amplified Dna AssayBecton, Dickinson & CO · 2014
  • K140448BD Probetec Neisseria Gonorrhoeae (GC) QX Amplified Dna AssayBecton, Dickinson & CO · 2014

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/K022875 · printed Nov 5, 2026

Cite this page

510(k) Report. “K022875: Modification to BD Vacutainer Push Button Blood Collection Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K022875

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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