# K771370: Icrotaineo Brand Tube

- Pathway: 510(k) (Traditional)
- Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic
- Decided: Aug 3, 1977 after 9 days
- Product code: GJE (Tray, 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
No predicates in its family tree.
3 later devices descend from it; 1 cites it directly.
0 of 4 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

## Recalls of this device
- 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/K771370
Methodology: https://510kreport.com/methodology