# K032827: Kendall Lifetrace Umbilical Blood Collection Kit, Code 56501

- Pathway: 510(k) (Traditional)
- Applicant: Tyco Healthcare
- Decided: Dec 8, 2003 after 89 days
- Product code: KSR (Container, Empty, For Collection & Processing Of Blood & Blood Components)
- Device class: 2
- Regulation: 21 CFR 864.9100
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K020753: Deroyal Surgical, Umbilicup, Deroyal (2002). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
The device is used for umbilical cord blood sampling and transfer. The device is intended for single use only.

Source page: https://510kreport.com/device/K032827
Methodology: https://510kreport.com/methodology