510(k) · Cleared

Cleared

Kendall Lifetrace Umbilical Blood Collection Kit, Code 56501

K032827510(k) TraditionalCleared Dec 8, 200389-day reviewClass II21 CFR 864.9100

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

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

Cleared on Dec 8, 2003 after an 89-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below).

Decided: Dec 8, 2003
Review: 89 days
Class: Class II
Product code: KSR
Recalls: None
Predicates: 1

The summary cites one number, which could not be confirmed as its predicate (see the table below).

FIG. 1 — Lineage of K032827Source: FDA 510(k) database · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and 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? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

Type	Number	Device	Applicant	Decided	Recalls
Kept off the family tree	K020753	FDA’s K020753 is Deroyal Surgical, Umbilicup Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree	Deroyal	2002	2

What descends from it?

No later submission names this one as a predicate yet.

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

No FDA recall names this device.

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?

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

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K032827 · printed Nov 4, 2026

Cite this page

510(k) Report. “K032827: Kendall Lifetrace Umbilical Blood Collection Kit, Code 56501.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K032827

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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