510(k) · Cleared

Cleared

Synchron Systems Dat Low and High Urine Calibrators II

K983747510(k) TraditionalCleared Dec 30, 199868-day reviewClass II21 CFR 862.3200

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

Beckman Coulter, Inc. · DKB Calibrators, Drug Mixture

Cleared on Dec 30, 1998 after a 68-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 2 later devices descend from it.

Decided: Dec 30, 1998
Review: 68 days
Class: Class II
Product code: DKB
Recalls: None
Predicates: 1

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

This deviceK983747 Synchron Systems Dat Low and High Urine Calibrators IIBeckman Coulter, Inc. · 1998
Descendant · cites it directly · 0 of its ownK993023 Synchron Systems OP 300 Low and High Urine ControlsBeckman Coulter, Inc. · 1999
Descendant · cites it directly · 0 of its ownK993022 Synchron Systems OP 300 Low and High Urine CalibratorsBeckman Coulter, Inc. · 1999

Most influential descendants

Showing 2 of 2 · See all

K993023Synchron Systems OP 300 Low and High Urine ControlsBeckman Coulter, Inc. · 1999 · cites it directly0descendants
K993022Synchron Systems OP 300 Low and High Urine CalibratorsBeckman Coulter, Inc. · 1999 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K983747	Synchron Systems Dat Low and High Urine Calibrators II	Beckman Coulter, Inc.	1998	—
+1	K993023	Synchron Systems OP 300 Low and High Urine Controls	Beckman Coulter, Inc.	1999	—
+1	K993022	Synchron Systems OP 300 Low and High Urine Calibrators	Beckman Coulter, Inc.	1999	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1999	2	0

FIG. 1 — Lineage of K983747, 1998–1999Source: 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 DKB? 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

Get a 510(k) Report

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	K985101	Drugs of Abuse Urine Calibrators II Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

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
K993023	Synchron Systems OP 300 Low and High Urine Controls	Beckman Coulter, Inc.	1999	0
K993022	Synchron Systems OP 300 Low and High Urine Calibrators	Beckman Coulter, Inc.	1999	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?

Of its descendants, K993023 (Beckman Coulter, Inc., 1999) has gone furthest, with 0 descendants of its own.

How does its category compare?

All DKB devices

DKB Calibrators, Drug Mixture: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DKB

2in 2014

2007high 2 (2009) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DKB

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

Recalls per year · DKB

2in 2022

2007high 3 (2009) · low 0 (2007)2026

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

Adverse event reports per year · DKB

1in 2017

2007high 4 (2012) · low 0 (2007)2025

MAUDE reports naming product code DKB, 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	—	0	0
2008	0	—	0	0
2009	2	—	3	0
2010	0	—	0	0
2011	2	—	2	1
2012	1	—	1	4
2013	0	—	0	0
2014	2	—	0	0
2015	0	—	0	0
2016	0	—	0	0
2017	0	—	0	1
2018	0	—	0	0
2019	0	—	0	0
2020	0	—	0	0
2021	0	—	0	0
2022	0	—	2	0
2023	0	—	0	0
2024	0	—	0	0
2025	0	—	0	0
2026	0	—	0	—

What is it indicated for?

The SYNCHRON® Systems DAT Low and High Urine Calibrators Ii, in conjunction with SYNCHRON Reagents, are intended for use on SYNCHRON Systems for the calibrations of Barbiturates, Benzodiazepine, Methadone, Opiate 300 ng, Methaqualone, and Propoxyphene enzyme immunoassays.

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/K983747 · printed Nov 6, 2026

Cite this page

510(k) Report. “K983747: Synchron Systems Dat Low and High Urine Calibrators II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K983747

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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