510(k) Report

510(k) · Cleared

Cleared

Terumo Venoject,Luer Adapter

K983490510(k) TraditionalCleared Nov 30, 199856-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

Terumo Corp. · JKA Tubes, Vials, Systems, Serum Separators, Blood Collection

Cleared on Nov 30, 1998 as substantially equivalent to K931367 (Bd Becton Dickinson Vacutainer Systems Preanalytic, 1993) after a 56-day review. Its family tree reaches back 1 generation to 1993. 21 later devices descend from it.

Decided
Nov 30, 1998
Review
56 days
Class
Class II
Product code
JKA
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K931367 (1993). 21 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 1999: 1 descendant cleared2001: 1 descendant cleared2004: 1 descendant cleared2003: 1 descendant cleared2019: 3 descendants cleared2025: 1 descendant cleared2016: 1 descendant cleared2020: 2 descendants cleared2005: 1 descendant cleared2015: 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 · 19931990200020102020
Descendants, by generation 1 generation forward: 3 descendants2 generations forward: 7 descendants3 generations forward: 10 descendants4 generations forward: 1 descendant K931367 · Vacutainer Brand Luer Adapter · Bd Becton Dickinson Vacutainer Systems Preanalytic · 19930
  1. Root · 1 generation backK931367 Vacutainer Brand Luer AdapterBd Becton Dickinson Vacutainer Systems Preanalytic · 1993
  2. This deviceK983490 Terumo Venoject,Luer AdapterTerumo Corp. · 1998
  3. Descendant · cites it directly · 14 of its ownK991088 Vacutainer Brand Multiple Sample Luer Adapter, Blood Collection Sets…Becton Dickinson Vacutainer Systems · 1999 · Recalled
  4. Descendant · 2 generations on · 6 of its ownK200027 Blood Collection Needle with/without Holder, Safety Blood Collection…Jiangsu Caina Medical Co.,Ltd · 2020
  5. Descendant · cites it directly · 4 of its ownK013164 Surshield Safety Winged Blood Collection SetTerumo Medical Corp. · 2001
  6. Descendant · 2 generations on · 3 of its ownK031279 Surshield Safety Winged Blood Collection SetTerumo Medical Products Hangzhou Co., Ltd. · 2003
  7. Descendant · 3 generations on · 1 of its ownK222478 BD Vacutainer® Luer-Lok™ Access Device, BD Vacutainer® Blood…Becton, Dickinson and Company · 2023

Showing 5 of 21 descendants. See all descendants

Descendants cleared per year

1999: 12001: 12003: 12004: 12005: 12015: 12016: 12018: 12019: 32020: 22022: 22023: 32024: 12025: 12026: 1
1999high 3 (2019) · low 0 (2000)2026

Most influential descendants

Showing 5 of 21 · See all
  • K991088Vacutainer Brand Multiple Sample Luer Adapter, Blood Collection Sets and Safety-Lok…Becton Dickinson Vacutainer Systems · 1999 · cites it directly14descendants
  • K200027Blood Collection Needle with/without Holder, Safety Blood Collection Needle with/without…Jiangsu Caina Medical Co.,Ltd · 2020 · 2 generations on6descendants
  • K013164Surshield Safety Winged Blood Collection SetTerumo Medical Corp. · 2001 · cites it directly4descendants
  • K031279Surshield Safety Winged Blood Collection SetTerumo Medical Products Hangzhou Co., Ltd. · 2003 · 2 generations on3descendants
  • K222478BD Vacutainer® Luer-Lok™ Access Device, BD Vacutainer® Blood Transfer DeviceBecton, Dickinson and Company · 2023 · 3 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K931367Vacutainer Brand Luer AdapterBd Becton Dickinson Vacutainer Systems Preanalytic1993—
0 (this device)K983490Terumo Venoject,Luer AdapterTerumo Corp.1998—
+1K991088Vacutainer Brand Multiple Sample Luer Adapter, Blood Collection Sets and…Becton Dickinson Vacutainer Systems19994
+2K200027Blood Collection Needle with/without Holder, Safety Blood Collection Needle…Jiangsu Caina Medical Co.,Ltd2020—
+1K013164Surshield Safety Winged Blood Collection SetTerumo Medical Corp.2001—
+2K031279Surshield Safety Winged Blood Collection SetTerumo Medical Products Hangzhou Co., Ltd.2003—
+3K222478BD Vacutainer® Luer-Lok™ Access Device, BD Vacutainer® Blood Transfer DeviceBecton, Dickinson and Company2023—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199910
200110
200310
200410
200510
201510
201610
201810
201930
202020
202220
202330
202410
202510
202610
FIG. 1 — Lineage of K983490, 1993–2026Source: 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
*K931367Vacutainer Brand Luer Adapter
Summary page 1
…this 510k is substantially equivalent in intended use, design, principle of operation, and materials to the cleared B-D® Vacutainer® Luer Adapter which is the subject of K931367. PRINCIPLE OF OPERATION/TECHNOLOGY The Terumo Venoject Luer Adapter and the B-D Vacutainer Luer Adapter are both operated manua…
Bd Becton Dickinson Vacutainer Systems Preanalytic1993—

Also cleared against K931367: 3 other devices →

What descends from it? (21)

See all 21

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

NumberDeviceApplicantDecidedDescendants
K991088Vacutainer Brand Multiple Sample Luer Adapter, Blood Collection Sets and Safety-Lok…Becton Dickinson Vacutainer Systems199914
K013164Surshield Safety Winged Blood Collection SetTerumo Medical Corp.20014
K041358Venoject Luer AdapterTerumo Europe N.V.20040

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?

  • Its one ancestor has no recall.
  • Of its descendants, K991088 (Becton Dickinson Vacutainer Systems, 1999) has gone furthest, with 14 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 Terumo Venoject Luer Adapter is a sterile, non-invasive device that permits blood specimen collection from hypodermic needles, blood vessel catheters, or blood collection systems/devices with luer fittings. When blood samples are to be obtained with a single venipuncture, the luer adapter is a conduit between the collection needle and the collection container.

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
  • K991088Vacutainer Brand Multiple Sample Luer Adapter, Blood Collection Sets and Safety-Lok Blood Collection, Safety…Becton Dickinson Vacutainer Systems · 19994 recalls

More from Terumo Corp.

21 FDA decisions under this applicant name. See the company

  • K100282Terumo Surshield- Pur Safety I.V. CatheterTerumo Corp. · 2010
  • K092372Heartrail Iii Guiding CatheterTerumo Corp. · 2009
  • K091417Single Use Guidewire, Models G-240-2527S, G-240-2545S, G-240-2527A, G-240-2545A, G-240-3527S, G-240-3545S &…Terumo Corp. · 2009
  • K090973Terumo Surshield Safety I.V. Catheter (18G X 51MM & 20G X 51MM Sizes)Terumo Corp. · 2009
  • K073474Capiox Circuit ConnectorsTerumo Corp. · 2008

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/K983490 · printed Nov 4, 2026

Cite this page

510(k) Report. “K983490: Terumo Venoject,Luer Adapter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K983490

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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