# K020753: Deroyal Surgical, Umbilicup

- Pathway: 510(k) (Traditional)
- Applicant: Deroyal
- Decided: Jun 13, 2002 after 98 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: 2 (0 Class I)
- 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Recalls of this device
- Jan 20, 2012 · Not classified · Z-1398-2012: Device's needle may become dislodged from the cup during shipment or during use.
- Jan 20, 2012 · Not classified · Z-1396-2012: Device's needle may become dislodged from the cup during shipment or during use.

## Indications for use
a single use only, cord blood sampling, transfer device. A blood collectiodtransfer device with a drinking glass shaped body, divided in half. The top half is used to collect umbilical cord blood for analysis and has a lid. The bottom half has a needle enclosed in rubber used to puncture the rubber caps of vacuum tubes and transfer the collected blood from the top chamber. It is 4 inches in length and 2.5 inches in width. The Uinbilicup is suitable for vaginal delivery and caesarean delivery. The Umbilicup reduces blood exposure and aids in blood gas collection and transport. Do not steam sterilize.

Source page: https://510kreport.com/device/K020753
Methodology: https://510kreport.com/methodology