510(k) · Cleared

Cleared

Creatinine Liquicolor

K050283510(k) TraditionalCleared Jun 30, 2005143-day reviewClass II21 CFR 862.1225

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

Stanbio Laboratory · JFY Enzymatic Method, Creatinine

Cleared on Jun 30, 2005 as substantially equivalent to K941837 (Roche Diagnostic Systems, Inc., 1994) after a 143-day review. Its family tree reaches back 1 generation to 1994. 1 later device descends from it.

Decided: Jun 30, 2005
Review: 143 days
Class: Class II
Product code: JFY
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K941837 (1994). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK941837 Roche Reagent for CreatinineRoche Diagnostic Systems, Inc. · 1994
This deviceK050283 Creatinine LiquicolorStanbio Laboratory · 2005
Descendant · cites it directly · 0 of its ownK161527 Teco Creatinine Enzymatic Reagent KitTeco Diagnostics, Inc. · 2017

Most influential descendants

Showing 1 of 1 · See all

K161527Teco Creatinine Enzymatic Reagent KitTeco Diagnostics, Inc. · 2017 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K941837	Roche Reagent for Creatinine	Roche Diagnostic Systems, Inc.	1994	—
0 (this device)	K050283	Creatinine Liquicolor	Stanbio Laboratory	2005	—
+1	K161527	Teco Creatinine Enzymatic Reagent Kit	Teco Diagnostics, Inc.	2017	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2017	1	0

FIG. 1 — Lineage of K050283, 1994–2017Source: 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 JFY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new JFY device

#1 K252619 Qscheck Uisacrscore 12.4 · 6 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin 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
*	K941837	Roche Reagent for Creatinine Summary page 1 …e: JFY Substantial Equivalence of Device This test is substantially equivalent to: Product Name: Creatinine Reagent 510(k) K941837 Roche Diagnostic Description of Device The Creatinine LiquiColor®0 test kit is comprised of two reagent…	Roche Diagnostic Systems, Inc.	1994	—

Also cleared against K941837: 6 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K161527	Teco Creatinine Enzymatic Reagent Kit	Teco Diagnostics, Inc.	2017	0

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.
Of its descendants, K161527 (Teco Diagnostics, Inc., 2017) has gone furthest, with 0 descendants of its own.
6 other devices also cite its predicate K941837.

How does its category compare?

All JFY devices

JFY Enzymatic Method, Creatinine: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JFY

2in 2021

2007high 8 (2007) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JFY

59in 2009

2007high 193 (2007) · low 59 (2009)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · JFY

1in 2013

2007high 3 (2009) · low 0 (2007)2026

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

Adverse event reports per year · JFY

61in 2025

2007high 61 (2025) · low 1 (2007)2025

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

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	8	193	0	1
2008	4	170	2	4
2009	3	59	3	22
2010	0	—	3	22
2011	2	—	0	42
2012	0	—	0	24
2013	0	—	1	39
2014	2	—	0	4
2015	0	—	0	7
2016	1	—	0	16
2017	1	—	0	16
2018	2	—	0	34
2019	2	—	0	56
2020	0	—	0	34
2021	2	—	0	57
2022	0	—	0	9
2023	0	—	0	36
2024	0	—	0	34
2025	0	—	0	61
2026	1	—	0	—

What is it indicated for?

The Stanbio Creatinine LiquiColor® test system is a device intended to measure creatinine levels in serum and urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K050283 · printed Nov 6, 2026

Cite this page

510(k) Report. “K050283: Creatinine Liquicolor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050283

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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