510(k) · Cleared

Recalled · 2012

Deroyal Surgical, Umbilicup

K020753510(k) TraditionalCleared Jun 13, 200298-day reviewClass II21 CFR 864.9100Recalls 2

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Deroyal · KSR Container, Empty, For Collection & Processing Of Blood & Blood Components

Cleared on Jun 13, 2002 after a 98-day review. FDA’s file for it is a 510(k) statement, which names no predicate. It has been recalled 2 times.

Decided: Jun 13, 2002
Review: 98 days
Class: Class II
Product code: KSR
Recalls: 2
Predicates: 0

FDA’s file for it is a 510(k) statement, which names no predicate.

FIG. 1 — Lineage of K020753Source: FDA 510(k) database · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in KSR? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

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What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Jan 20, 2012	Not classified	Z-1398-2012	Nonconforming Material/Component	Device's needle may become dislodged from the cup during shipment or during use.
Jan 20, 2012	Not classified	Z-1396-2012	Nonconforming Material/Component	Device's needle may become dislodged from the cup during shipment or during use.

No ancestor or descendant has a Class I recall.

How does its category compare?

All KSR devices

KSR Container, Empty, For Collection & Processing Of Blood & Blood Components: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KSR

FDA has decided no KSR device since 2007.

Median 510(k) review, days · KSR

Too few KSR 510(k)s in any year since 2007 to give a median.

Recalls per year · KSR

2in 2012

2007high 2 (2012) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · KSR

10in 2025

2007high 82 (2009) · low 3 (2018)2025

MAUDE reports naming product code KSR, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	—	0	46
2008	—	0	47
2009	—	0	82
2010	—	0	39
2011	—	0	11
2012	—	2	41
2013	—	0	71
2014	—	0	11
2015	—	0	8
2016	—	0	5
2017	—	0	4
2018	—	0	3
2019	—	0	9
2020	—	0	21
2021	—	0	17
2022	—	0	11
2023	—	0	20
2024	—	0	25
2025	—	0	10
2026	—	0	—

What is it indicated for?

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.

Indications for use as stated in the FDA 510(k) statement.

https://510kreport.com/device/K020753 · printed Nov 6, 2026

Cite this page

510(k) Report. “K020753: Deroyal Surgical, Umbilicup.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020753

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Page last updated Nov 3, 2026