SAFE-T-FILL CAPILLARY BLOOD COLLECTION SYSTEM— 510(k) K981973

Clearance details

Applicant

Ram Scientific

Product code

Code JKA

Device class

Class 2

Regulation

21 CFR 862.1675

Advisory panel

Clinical Chemistry

Date received

1998-06-05

Decision date

1998-09-03

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Washington, DC, US

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• 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

• K983517 — SAFE-T-FILL CAPILLARY BLOOD COLLECTION SYSTEM1998-11-12

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 →

• Z-0372-2026 — SAFE-T-FILL Micro Capillary Blood Collection, 125 ¿L Prepared with Dipotassium EDTA Purple, Model: 07 6011; SAFE-T-FILL Micro Capillary Blood Collection, 125 ¿L Prepared with Dipotassium EDTA Self-sealing Cap, Purple, Model: 07 6013; SAFE-T-FILL Micro Capillary Blood Collection, 200 ¿L Prepared with Dipotassium EDTA Purple, Model: 07 7051; SAFE-T-FILL Micro Capillary Blood Collection, 150 ¿L Prepared with Dipotassium EDTA Purple, Model: 07 7052; SAFE-T-FILL Micro Capillary Blood Collection, 300 ¿L Prepared with Dipotassium EDTA Purple, Model: 07 7053; SAFE-T-FILL Micro Capillary Blood Collection, 200 ¿L Prepared with Dipotassium EDTA Purple, Model: 07 7056; SAFE-T-FILL Micro Capillary Blood Collection, 200 ¿L Prepared with Dipotassium EDTA Flat Bottom Microtube, Purple, Model: 07 7058 SAFE-T-FILL¿ End-to-End Capillary Tubes, 30 ¿L; Plastic, Prepared with EDTA Dipotassium Model: 06 0910Class II·Ongoing·ASP Global, LLC. dba Anatomy Supply Partners, LLC.·20250505

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K981973.