510(k) Report

510(k) · Cleared

Recalled · Class III · 2022

Vacutainer Brand Multiple Sample Luer Adapter, Blood Collection Sets and Safety-Lok Blood Collection, Safety Blood Colle

K991088510(k) TraditionalCleared May 28, 199957-day reviewClass II21 CFR 862.1675Recalls 4

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

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

Cleared on May 28, 1999 as substantially equivalent to K931367 (Bd Becton Dickinson Vacutainer Systems Preanalytic, 1993) and 1 other predicate after a 57-day review. Its family tree reaches back 2 generations to 1993. 14 later devices descend from it. It has been recalled 4 times.

Decided
May 28, 1999
Review
57 days
Class
Class II
Product code
JKA
Recalls
4
Predicates
2

Its longest line of descent runs back 2 generations to K931367 (1993). 14 later devices descend from it, 6 citing it directly.

Descendants, by year cleared 2019: 3 descendants cleared2025: 1 descendant cleared2016: 1 descendant cleared2020: 1 descendant cleared2018: 1 descendant cleared2023: 3 descendants cleared2022: 2 descendants cleared2024: 1 descendant cleared2026: 1 descendant clearedK931367 · Vacutainer Brand Luer Adapter · Bd Becton Dickinson Vacutainer Systems Preanalytic · 1993K983490 · Terumo Venoject,Luer Adapter · Terumo Corp. · 19981990200020102020
Descendants, by generation 1 generation forward: 6 descendants2 generations forward: 7 descendants3 generations forward: 1 descendant K983490 · Terumo Venoject,Luer Adapter · Terumo Corp. · 1998K931367 · Vacutainer Brand Luer Adapter · Bd Becton Dickinson Vacutainer Systems Preanalytic · 19930
  1. Root · 2 generations backK931367 Vacutainer Brand Luer AdapterBd Becton Dickinson Vacutainer Systems Preanalytic · 1993
  2. 1 generation backK983490 Terumo Venoject,Luer AdapterTerumo Corp. · 1998
  3. This deviceK991088 Vacutainer Brand Multiple Sample Luer Adapter, Blood Collection Sets…Becton Dickinson Vacutainer Systems · 1999
  4. Descendant · cites it directly · 6 of its ownK200027 Blood Collection Needle with/without Holder, Safety Blood Collection…Jiangsu Caina Medical Co.,Ltd · 2020
  5. Descendant · 2 generations on · 1 of its ownK222478 BD Vacutainer® Luer-Lok™ Access Device, BD Vacutainer® Blood…Becton, Dickinson and Company · 2023
  6. Descendant · cites it directly · 1 of its ownK190485 Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH)Kawasumi Laboratories, Inc. · 2019
  7. Descendant · cites it directly · 1 of its ownK160532 Greiner HoldexGreiner Bio-One Na, Inc. · 2016
  8. Descendant · 3 generations on · 0 of its ownK252899 Female Culture Device; Male Culture Device; Transfer Device; Access…Zhejiang Kindly Medical Device Co., Ltd. · 2026

Showing 5 of 14 descendants. See all descendants

Descendants cleared per year

2016: 12018: 12019: 32020: 12022: 22023: 32024: 12025: 12026: 1
2016high 3 (2019) · low 0 (2017)2026

Most influential descendants

Showing 5 of 14 · See all
  • K200027Blood Collection Needle with/without Holder, Safety Blood Collection Needle with/without…Jiangsu Caina Medical Co.,Ltd · 2020 · cites it directly6descendants
  • K222478BD Vacutainer® Luer-Lok™ Access Device, BD Vacutainer® Blood Transfer DeviceBecton, Dickinson and Company · 2023 · 2 generations on1descendant
  • K190485Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH)Kawasumi Laboratories, Inc. · 2019 · cites it directly1descendant
  • K160532Greiner HoldexGreiner Bio-One Na, Inc. · 2016 · cites it directly1descendant
  • K252899Female Culture Device; Male Culture Device; Transfer Device; Access DeviceZhejiang Kindly Medical Device Co., Ltd. · 2026 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K931367Vacutainer Brand Luer AdapterBd Becton Dickinson Vacutainer Systems Preanalytic1993—
−1K983490Terumo Venoject,Luer AdapterTerumo Corp.1998—
0 (this device)K991088Vacutainer Brand Multiple Sample Luer Adapter, Blood Collection Sets and…Becton Dickinson Vacutainer Systems1999—
+1K200027Blood Collection Needle with/without Holder, Safety Blood Collection Needle…Jiangsu Caina Medical Co.,Ltd2020—
+2K222478BD Vacutainer® Luer-Lok™ Access Device, BD Vacutainer® Blood Transfer DeviceBecton, Dickinson and Company2023—
+1K190485Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH)Kawasumi Laboratories, Inc.2019—
+1K160532Greiner HoldexGreiner Bio-One Na, Inc.2016—
+3K252899Female Culture Device; Male Culture Device; Transfer Device; Access DeviceZhejiang Kindly Medical Device Co., Ltd.2026—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201610
201810
201930
202010
202220
202330
202410
202510
202610
FIG. 1 — Lineage of K991088, 1993–2026Source: 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? (2)

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
*K931367Vacutainer Brand Luer Adapter
Summary page 3
…The predicate devices, K number, and clearance date are also identified in the table below. Manufacturer Predicate Device K-Number Cléarance Date Be_cton VACUTAINER® | K931367 5/18/93 Dickinson Brand Multiple VACUTAINER | Sample Luer Systems Adapter Terumo Medical TERUMO® K 983490 11/30/98 Corporation Br…
Bd Becton Dickinson Vacutainer Systems Preanalytic1993—
*K983490Terumo Venoject,Luer Adapter
Summary page 3
…r Predicate Device K-Number Cléarance Date Be_cton VACUTAINER® | K931367 5/18/93 Dickinson Brand Multiple VACUTAINER | Sample Luer Systems Adapter Terumo Medical TERUMO® K 983490 11/30/98 Corporation Brand - VENOJECT™ Luer Adapter Cfim Aoz, Dhme Lh i 3i, 49 Andrea Hroncich Date Regulatery Affairs Associate…
Terumo Corp.1998—

Also cleared against K931367: 3 other devices →

What descends from it? (14)

See all 14

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

NumberDeviceApplicantDecidedDescendants
K200027Blood Collection Needle with/without Holder, Safety Blood Collection Needle with/without…Jiangsu Caina Medical Co.,Ltd20206
K190485Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH)Kawasumi Laboratories, Inc.20191
K160532Greiner HoldexGreiner Bio-One Na, Inc.20161
K243649BD Vacutainer® Multiple Sample Luer AdapterBecton, Dickinson and Company20250
K181743Blood Transfer Accessory (BTA)Nsp Tech Pte, Ltd.20190
K181754Blood Collection Accessory (BUCA)Nsp Tech Pte, Ltd.20190

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

Recalls of this device

DateClassRecallRoot causeReason
Feb 24, 2022Class IIIZ-0837-2022Material/Component ContaminationRecalled devices were packaged in convenience kits.
Jan 6, 2022Class IIIZ-0665-2022Under Investigation by firmMay shed contaminant particles into the urine specimen that may be misidentified as Red Blood Cells when used in conjunction with the Sysmex UF-1000i or UX-2000 Analyzers and lead to false elevations in RBC counts
Sep 8, 2006Not classifiedZ-0253-2007OtherReports of failure of the Luer Lok Access Device to lock securely to certain catheter devices because the male luer taper surface is not within the specification.
Jun 21, 2006Not classifiedZ-1462-06OtherFirm received complaints indicating failure of the Non-Patient (NP) sleeve to function properly. This sleeve covers the cannula and prevents leakage during blood collection.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 6 years and passes through 3 companies; a new generation was cleared every 5.6 years on median.
  • None of the 2 ancestors has a recall.
  • Of its descendants, K200027 (Jiangsu Caina Medical Co.,Ltd, 2020) has gone furthest, with 6 descendants of its own.
  • 3 other devices also cite its predicate K931367.

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 Luer Adapter is a sterile, non-invasive device used to connect venous access devices such as needles, blood collection sets, and infusion sets to blood collection tubes. They are also used in connection with non-needle devices for collection of blood from catheters. The VACUTAINER® Brand Luer Adapter is sold by itself and as a component of other VACUTAINER Brand devices.

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

Also cleared against K931367

3 other devices cite the same predicate.

  • K021475BD Single Lumen Needle, Syringe and Blood Collection SetBd · 20023 recalls
  • K011984BD Vacutainer Push Button Blood Colection SetBecton, Dickinson & CO · 20017 recalls
  • K983490Terumo Venoject,Luer AdapterTerumo Corp. · 1998

More from Becton Dickinson Vacutainer Systems

15 FDA decisions under this applicant name. See the company

  • K002456Microtainer Brand Sodium Fluoride/Edta Tube with Microgard Closure, Model 365992Becton Dickinson Vacutainer Systems · 200010 recalls
  • K991702Microtainer Brand Chemistry Tubes with Microgard Closure, Model 365965, 365985, 365963, 365967, 36578Becton Dickinson Vacutainer Systems · 19999 recalls
  • K991120Vacutainer Brand Ctad Tube (Multiple)Becton Dickinson Vacutainer Systems · 1999
  • K982541Vacutainer Brand Eclipse Blood Collection Needle, Models# 368607 & 368608Becton Dickinson Vacutainer Systems · 19981 recall
  • K982922Vacutainer Brand Blood Collection SyringeBecton Dickinson Vacutainer Systems · 1998

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/K991088 · printed Nov 5, 2026

Cite this page

510(k) Report. “K991088: Vacutainer Brand Multiple Sample Luer Adapter, Blood Collection Sets and Safety-Lok Blood Collection, Safety Blood Colle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K991088

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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