# K931368: Microtainer Brand Tube with Edta

- Pathway: 510(k) (Traditional)
- Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic
- Decided: Sep 28, 1993 after 195 days
- Product code: JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection)
- Device class: 2
- Regulation: 21 CFR 862.1675
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
5 later devices descend from it; 3 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K991702: Microtainer Brand Chemistry Tubes with Microgard Closure, Model 365965, 365985, 365963, 365967, 36578 (1999), 2 descendants of its own
- K230391: BD MiniDraw™ Capillary Blood Collection System with BD MiniDraw™ SST™ Capillary Blood Collection Tube (2023), 1 descendant of its own
- K252378: BD® MiniDraw™ Capillary Blood Collection System with BD® MiniDraw™ SST™ Capillary Blood Collection Tube (2026), 0 descendants of its own
- K983517: Safe-T-Fill Capillary Blood Collection System (1998), 0 descendants of its own
- K981973: Safe-T-Fill Capillary Blood Collection System (1998), 0 descendants of its own

## Recalls of this device
- Jun 3, 2019 · Class II · Z-1967-2019: The products have been confirmed to have reduced or no additive within the tube reservoir. The tubes may develop visible clots within the tube samples or micro clots that are not easily detected durin
- Aug 20, 2004 · Not classified · Z-1603-05: "Please be aware that this is not a new recall. This recall was initially classified in 2005 (Z-0052-05). The firm has taken action; but, due to administrative issues additional products are now being

Source page: https://510kreport.com/device/K931368
Methodology: https://510kreport.com/methodology