# K981973: Safe-T-Fill Capillary Blood Collection System

- Pathway: 510(k) (Traditional)
- Applicant: Ram Scientific
- Decided: Sep 3, 1998 after 90 days
- Product code: JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection)
- Device class: 2
- Regulation: 21 CFR 862.1675
- Recalls of this device: 1 (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
- May 5, 2025 · Class II · Z-0372-2026: All RAM SAFE-T-FILL Micro Capillary Blood Collection tubes manufactured between July 31, 2023 to February 28, 2025 cause false positive results when used with Magellan Diagnostics LeadCare Testing Sys

## 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 hematology testing.

Source page: https://510kreport.com/device/K981973
Methodology: https://510kreport.com/methodology