510(k) Report

510(k) · Cleared

Cleared

Blood Transfer Accessory (BTA)

K181743510(k) TraditionalCleared Jul 30, 2019393-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

Nsp Tech Pte, Ltd. · JKA Tubes, Vials, Systems, Serum Separators, Blood Collection

Cleared on Jul 30, 2019 as substantially equivalent to K991088 (Becton Dickinson Vacutainer Systems, 1999) after a 393-day review. Its family tree reaches back 3 generations to 1993.

Decided
Jul 30, 2019
Review
393 days
Class
Class II
Product code
JKA
Recalls
None
Predicates
1

Its longest line of descent runs back 3 generations to K931367 (1993). No later device cites it as a predicate yet.

  1. Root · 3 generations backK931367 Vacutainer Brand Luer AdapterBd Becton Dickinson Vacutainer Systems Preanalytic · 1993
  2. 2 generations backK983490 Terumo Venoject,Luer AdapterTerumo Corp. · 1998
  3. 1 generation backK991088 Vacutainer Brand Multiple Sample Luer Adapter, Blood Collection Sets…Becton Dickinson Vacutainer Systems · 1999 · Recalled
  4. This deviceK181743 Blood Transfer Accessory (BTA)Nsp Tech Pte, Ltd. · 2019
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K931367Vacutainer Brand Luer AdapterBd Becton Dickinson Vacutainer Systems Preanalytic1993—
−2K983490Terumo Venoject,Luer AdapterTerumo Corp.1998—
−1K991088Vacutainer Brand Multiple Sample Luer Adapter, Blood Collection Sets and…Becton Dickinson Vacutainer Systems19994
0 (this device)K181743Blood Transfer Accessory (BTA)Nsp Tech Pte, Ltd.2019—
FIG. 1 — Lineage of K181743, 1993–2019Source: 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
*K991088Vacutainer Brand Multiple Sample Luer Adapter, Blood Collection Sets and Safety-Lok…
Summary page 4
…: JKA Panel : Clinical Chemistry 3. PREDICATE DEVICE Vacutainer® Brand Multiple Sample Luer Adapter 510(k) Number: K991088 Regulatory Class: Class II Regulation Number: 21 CFR 862.1675 Product Code: JKA 4. DEVICE D…
Becton Dickinson Vacutainer Systems19994

Also cleared against K991088: 5 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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 26 years and passes through 4 companies; a new generation was cleared every 5.6 years on median.
  • 1 of the 3 ancestors has a recall of any class.
  • 5 other devices also cite its predicate K991088.

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. 2019, this device’s year, is highlighted.

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 Blood Transfer Accessory is a sterile non invasive device for use in venous blood collection procedures in combination with blood collection devices with a male luer feature.

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

Cite this page

510(k) Report. “K181743: Blood Transfer Accessory (BTA).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181743

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