510(k) Report

FDA applicant

Ram Scientific

Washington, DC2 decisions1998–199812 recalls

FDA records 2 decisions for Ram Scientific (Washington, DC) in 1998: 2 510(k) clearances. All are in product code JKA (Tubes, Vials, Systems, Serum Separators, Blood…). Its devices cite 6 predicates, 0 of them its own earlier devices. 12 recalls are linked to its devices.

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

FIG. A — Illustration, clinical chemistry panel, where it files most

How often FDA has decided Ram Scientific’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Ram Scientific since 2007.

Recalls per year

12in 2025

2025: 12
2007high 12 (2025) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Ram Scientific by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Ram Scientific’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • JKATubes, Vials, Systems, Serum Separators, Blood Collection2decisions

Whose devices does it build on?

Its devices cite 6 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K983517Safe-T-Fill Capillary Blood Collection SystemRam Scientific · 199811 recalls
  • K981973Safe-T-Fill Capillary Blood Collection SystemRam Scientific · 19981 recall

All 2 as Ram Scientific →

What has been recalled?

12 recalls linked to its devices; the latest:

  • K983517SAFE-T-FILL Micro Capillary Blood Collection, 200 L; Prepared with Clot Activator; Red…Sep 26, 2025Class II
  • K983517SAFE-T-FILL Micro Capillary Blood Collection, 300 L; Prepared with Clot Activator; Red…Sep 26, 2025Class II
  • K983517SAFE-T-FILL Micro Capillary Blood Collection, 200 L; Prepared with Lithium Heparin…Sep 26, 2025Class II
  • K983517SAFE-T-FILL Micro Capillary Blood Collection, 300 L; Prepared with Lithium Heparin…Sep 26, 2025Class II
  • K983517SAFE-T-FILL Micro Capillary Blood Collection, 200 L; Prepared with Clot Activator and…Sep 26, 2025Class II
  • K983517AFE-T-FILL Micro Capillary Blood Collection, 200 L; Prepared with Lithium Heparin and…Sep 26, 2025Class II