# K983517: Safe-T-Fill Capillary Blood Collection System

- Pathway: 510(k) (Traditional)
- Applicant: Ram Scientific
- Decided: Nov 12, 1998 after 36 days
- Product code: JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection)
- Device class: 2
- Regulation: 21 CFR 862.1675
- Recalls of this device: 11 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K833475 (1983). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K896206: Statspin Statsampler, Statspin Technologies (1989) Summary page 1.
- K833475: Capiject Sys Capillary Blood Collect, Terumo Medical Corp. (1983) Summary page 1.
- K931368: Microtainer Brand Tube with Edta, Bd Becton Dickinson Vacutainer Systems Preanalytic (1993) Summary page 1.

## Recalls of this device
- Sep 26, 2025 · Class II · Z-0547-2026: Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
- Sep 26, 2025 · Class II · Z-0548-2026: Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
- Sep 26, 2025 · Class II · Z-0551-2026: Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
- Sep 26, 2025 · Class II · Z-0552-2026: Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
- Sep 26, 2025 · Class II · Z-0545-2026: Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
- Sep 26, 2025 · Class II · Z-0549-2026: Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
- Sep 26, 2025 · Class II · Z-0544-2026: Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
- Sep 26, 2025 · Class II · Z-0546-2026: Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
- Sep 26, 2025 · Class II · Z-0550-2026: Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
- Sep 26, 2025 · Class II · Z-0553-2026: Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
- Sep 26, 2025 · Class II · Z-0554-2026: Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.

## Indications for use
The SAFE-T-FILL® Capillary Blood Collection System is indicated for the drawing of blood via capillary action from a finger or heelstick to be placed in a microtube for the purposes of obtaining a blood sample for diagnostic testing.

Source page: https://510kreport.com/device/K983517
Methodology: https://510kreport.com/methodology