510(k) · Cleared

Cleared

CueSee Hypoxic

K152553510(k) TraditionalCleared Apr 22, 2016227-day reviewClass I21 CFR 862.1660

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

Eurotrol B.V. · JJS Controls For Blood-Gases, (Assayed And Unassayed)

Cleared on Apr 22, 2016 as substantially equivalent to K032453 (Bionostics, Inc., 2003) after a 227-day review. Its family tree reaches back 2 generations to 1991.

Decided: Apr 22, 2016
Review: 227 days
Class: Class I
Product code: JJS
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K913133 (1991). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK913133 Chality Control Material (Assayed & Unassayed)Bionostics, Inc. · 1991
1 generation backK032453 Roche Combitrol and Autotrol Plus B Multi Analyte ControlBionostics, Inc. · 2003
This deviceK152553 CueSee HypoxicEurotrol B.V. · 2016

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K913133	Chality Control Material (Assayed & Unassayed)	Bionostics, Inc.	1991	—
−1	K032453	Roche Combitrol and Autotrol Plus B Multi Analyte Control	Bionostics, Inc.	2003	—
0 (this device)	K152553	CueSee Hypoxic	Eurotrol B.V.	2016	—

FIG. 1 — Lineage of K152553, 1991–2016Source: 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 JJS? 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
*	K032453	Roche Combitrol and Autotrol Plus B Multi Analyte Control Summary page 4 ….1660) 5. Predicate Device Device Name: RNA Medical® Brand QC 823 Range Blood Gas Electrolyte Metabolite Control Manufacturer: Bionostics, Inc., 510(k) number: k032453, Decision Date: 08/28/2003 6. Intended Use CueSee® Hypoxic is a pre-tonometered bovine hemoglobin (Hb) quality control mat…	Bionostics, Inc.	2003	—

Also cleared against K032453: 3 other devices →

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?

The line of descent spans 25 years and passes through 2 companies; a new generation was cleared every 12.7 years on median.
None of the 2 ancestors has a recall.
3 other devices also cite its predicate K032453.

How does its category compare?

All JJS devices

JJS Controls For Blood-Gases, (Assayed And Unassayed): FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.

FDA decisions per year · JJS

1in 2016

2007high 2 (2013) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JJS

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

Recalls per year · JJS

No recall names JJS since 2007.

Adverse event reports per year · JJS

1in 2018

2007high 1 (2017) · low 0 (2007)2025

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

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	0
2008	0	—	0
2009	0	—	0
2010	0	—	0
2011	0	—	0
2012	0	—	0
2013	2	—	0
2014	0	—	0
2015	1	—	0
2016	1	—	0
2017	0	—	1
2018	0	—	1
2019	0	—	0
2020	0	—	0
2021	0	—	0
2022	0	—	0
2023	0	—	0
2024	0	—	0
2025	0	—	0
2026	0	—	—

What is it indicated for?

CueSee® Hypoxic is a pre-tonometered bovine hemoglobin (Hb) quality control material for professional use for

monitoring blood gas analyzers’ performance of Oxygen partial pressure (pO2).

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K152553 · printed Nov 6, 2026

Cite this page

510(k) Report. “K152553: CueSee Hypoxic.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152553

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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