# K991702: Microtainer Brand Chemistry Tubes with Microgard Closure, Model 365965, 365985, 365963, 365967, 36578

- Pathway: 510(k) (Traditional)
- Applicant: Becton Dickinson Vacutainer Systems
- Decided: Jul 28, 1999 after 70 days
- Product code: JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection)
- Device class: 2
- Regulation: 21 CFR 862.1675
- Recalls of this device: 9 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K771370 (1977). 2 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K771370: Icrotaineo Brand Tube, Bd Becton Dickinson Vacutainer Systems Preanalytic (1977) Summary page 3.
- K931368: Microtainer Brand Tube with Edta, Bd Becton Dickinson Vacutainer Systems Preanalytic (1993) Summary page 3.

## Most influential descendants
- 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

## Recalls of this device
- May 13, 2019 · Class II · Z-0055-2020: Damaged reservoir may lead to a decreased fill volume causing samples to be insufficient for testing and improper blood-to-additive ratio, potentially producing erroneous results.
- May 13, 2019 · Class II · Z-0058-2020: Damaged reservoir may lead to a decreased fill volume causing samples to be insufficient for testing and improper blood-to-additive ratio, potentially producing erroneous results.
- May 13, 2019 · Class II · Z-0059-2020: Damaged reservoir may lead to a decreased fill volume causing samples to be insufficient for testing and improper blood-to-additive ratio, potentially producing erroneous results.
- May 13, 2019 · Class II · Z-0054-2020: Damaged reservoir may lead to a decreased fill volume causing samples to be insufficient for testing and improper blood-to-additive ratio, potentially producing erroneous results.
- May 13, 2019 · Class II · Z-0056-2020: Damaged reservoir may lead to a decreased fill volume causing samples to be insufficient for testing and improper blood-to-additive ratio, potentially producing erroneous results.
- May 13, 2019 · Class II · Z-0057-2020: Damaged reservoir may lead to a decreased fill volume causing samples to be insufficient for testing and improper blood-to-additive ratio, potentially producing erroneous results.
- May 13, 2019 · Class II · Z-0060-2020: Damaged reservoir may lead to a decreased fill volume causing samples to be insufficient for testing and improper blood-to-additive ratio, potentially producing erroneous results.
- May 13, 2019 · Class II · Z-0061-2020: Damaged reservoir may lead to a decreased fill volume causing samples to be insufficient for testing and improper blood-to-additive ratio, potentially producing erroneous results.
- 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

## Indications for use
The MICROTAINER® Brand Chemistry tubes with MICROGARD™ Closure are intended to collect, transport, and store skin puncture blood specimens for chemistry determinations requiring serum or heparinized plasma.

Source page: https://510kreport.com/device/K991702
Methodology: https://510kreport.com/methodology