Clearance details

Applicant: Sims Portex, Inc.
Product code: Code JKA
Device class: Class 2
Regulation: 21 CFR 862.1675
Advisory panel: Clinical Chemistry
Date received: 1998-03-19
Decision date: 1998-04-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Keene, NH, US

Recent devices under product code JKA

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K252899 — Female Culture Device; Male Culture Device; Transfer Device; Access Device2026-06-02
K260128 — BD Preset and BD A-Line Arterial Blood Collection Syringes2026-04-15
K252378 — BD® MiniDraw Capillary Blood Collection System with BD® MiniDraw SST Capillary Blood Collection Tube2026-04-10
K252506 — BD Vacutainer® Safety-Lok Blood Collection Set; BD Vacutainer® Safety-Lok Blood Collection Set with Pre-Attached Holder2026-04-10
K252040 — BD Vacutainer® Plasma Separator Tubes (PST), BD Vacutainer® Sodium Heparin Blood Collection Tubes2026-03-13

More clearances from Sims Portex, Inc.

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Adverse events under product code JKA

product code JKA

Injury: 455
Malfunction: 26,686
Other: 4
Total: 27,145

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K981035

K-number listed on FDA's recall record

Z-3196-2018 — Portex Pulsator Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes, REF 4080P-2, Sterile, RX. The firm name on the label is Smiths Medical ASD, Inc., Keene, NH.Class III·Terminated·Smiths Medical ASD Inc.·20180713

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K981035.