510(k) · Cleared

Cleared

Customed Blood Extraction Kit

K962596510(k) TraditionalCleared Sep 27, 199687-day reviewClass II21 CFR 862.1675

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

Customed, Inc. · GJE Tray, Blood Collection

Cleared on Sep 27, 1996 as substantially equivalent to K905464 (Angiosystems, Inc., 1991) after an 87-day review. Its family tree reaches back 1 generation to 1991.

Decided: Sep 27, 1996
Review: 87 days
Class: Class II
Product code: GJE
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K905464 (1991). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK905464 Medical Procedure Kits/Arterial Blood SamplingAngiosystems, Inc. · 1991
This deviceK962596 Customed Blood Extraction KitCustomed, Inc. · 1996

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K905464	Medical Procedure Kits/Arterial Blood Sampling	Angiosystems, Inc.	1991	—
0 (this device)	K962596	Customed Blood Extraction Kit	Customed, Inc.	1996	—

FIG. 1 — Lineage of K962596, 1991–1996Source: FDA 510(k) summaries, read by 510(k) Report · 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 GJE? 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.

Type	Number	Device	Applicant	Decided	Recalls
*	K905464	Medical Procedure Kits/Arterial Blood Sampling Summary page 1 …ustomed Blood Extraction kit is substantially equivalent in intended use, and kit contents as various blood collection kits legally marketed by Angiosystems, Inc. under K905464/A. Description of the Subjected Devices: The Customed Blood Collection Kits are an assembly of medical products within a pouch.…	Angiosystems, Inc.	1991	—

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.

What does this lineage say?

Its one ancestor has no recall.

How does its category compare?

All GJE devices

GJE Tray, Blood Collection: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GJE

FDA has decided no GJE device since 2007.

Median 510(k) review, days · GJE

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

Recalls per year · GJE

1in 2023

2007high 1 (2023) · low 0 (2007)2026

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

Adverse event reports per year · GJE

3in 2014

2007high 7 (2007) · low 0 (2011)2025

MAUDE reports naming product code GJE, 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	7
2008	—	0	3
2009	—	0	3
2010	—	0	3
2011	—	0	0
2012	—	0	1
2013	—	0	3
2014	—	0	3
2015	—	0	0
2016	—	0	0
2017	—	0	0
2018	—	0	0
2019	—	0	0
2020	—	0	0
2021	—	0	0
2022	—	0	0
2023	—	1	0
2024	—	0	0
2025	—	0	0
2026	—	0	—

What is it indicated for?

The Customed Blood Collection Kits are intended to be used by Healthcare professions for venous blood specimen collection and transport, and is for In-Vitro Diagnostic Use only. The kit is used to prepare the skin for sampling, provide blood collection tubes and needles for the sampling procedure, and to cover the sampling site when the procedure is complete.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K962596 · printed Nov 6, 2026

Cite this page

510(k) Report. “K962596: Customed Blood Extraction Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K962596

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Record history

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