510(k) · Cleared

Recalled · 2003

TDX Salicylate

K844070510(k) TraditionalCleared Nov 27, 198440-day reviewClass II21 CFR 862.3830Recalls 1

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

Abbott Laboratories · DKJ Colorimetry, Salicylate

Cleared on Nov 27, 1984 after a 40-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it. It has been recalled once.

Decided: Nov 27, 1984
Review: 40 days
Class: Class II
Product code: DKJ
Recalls: 1
Predicates: 0

2 later devices descend from it, 2 citing it directly.

This deviceK844070 TDX SalicylateAbbott Laboratories · 1984
Descendant · cites it directly · 0 of its ownK020794 Salicylate Assay for the Advia Integrated Modular SystemBayer Diagnostics Corp. · 2002
Descendant · cites it directly · 0 of its ownK014173 Synchron Systems Salicylate Reagent and CalibratorBeckman Coulter, Inc. · 2002 · Recalled

Most influential descendants

Showing 2 of 2 · See all

K020794Salicylate Assay for the Advia Integrated Modular SystemBayer Diagnostics Corp. · 2002 · cites it directly0descendants
K014173Synchron Systems Salicylate Reagent and CalibratorBeckman Coulter, Inc. · 2002 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K844070	TDX Salicylate	Abbott Laboratories	1984	—
+1	K020794	Salicylate Assay for the Advia Integrated Modular System	Bayer Diagnostics Corp.	2002	—
+1	K014173	Synchron Systems Salicylate Reagent and Calibrator	Beckman Coulter, Inc.	2002	2

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	2	0

FIG. 1 — Lineage of K844070, 1984–2002Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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 has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (2)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K020794	Salicylate Assay for the Advia Integrated Modular System	Bayer Diagnostics Corp.	2002	0
K014173	Synchron Systems Salicylate Reagent and Calibrator	Beckman Coulter, Inc.	2002	0

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Dec 5, 2003	Not classified	Z-0509-04	Other	The reagent package inserts for the products contain incorrect information in the Specific Performance Characteristics section. % Recovery incorrect.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Of its descendants, K020794 (Bayer Diagnostics Corp., 2002) has gone furthest, with 0 descendants of its own.

How does its category compare?

All DKJ devices

DKJ Colorimetry, Salicylate: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DKJ

1in 2010

2007high 1 (2010) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DKJ

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

Recalls per year · DKJ

1in 2013

2007high 1 (2007) · low 0 (2008)2026

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

Adverse event reports per year · DKJ

1in 2020

2007high 5 (2008) · low 0 (2010)2025

MAUDE reports naming product code DKJ, 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	0	—	1	1
2008	0	—	0	5
2009	0	—	0	1
2010	1	—	0	0
2011	0	—	0	3
2012	0	—	0	1
2013	0	—	1	1
2014	0	—	0	0
2015	0	—	0	0
2016	0	—	0	0
2017	0	—	0	0
2018	0	—	0	0
2019	0	—	0	0
2020	0	—	0	1
2021	0	—	0	0
2022	0	—	0	0
2023	0	—	0	0
2024	0	—	0	0
2025	0	—	0	0
2026	0	—	0	—

https://510kreport.com/device/K844070 · printed Nov 5, 2026

Cite this page

510(k) Report. “K844070: TDX Salicylate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K844070

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026