510(k) · Cleared

Cleared

Dimension C4 Flex Reagent Cartridge

K994293510(k) TraditionalCleared Mar 1, 200071-day reviewClass II21 CFR 866.5240

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

Dade Behring, Inc. · DBI Complement C4, Antigen, Antiserum, Control

Cleared on Mar 1, 2000 as substantially equivalent to K780913 (Beckman Instruments, Inc., 1978) and 1 other predicate after a 71-day review. Its family tree reaches back 1 generation to 1978.

Decided: Mar 1, 2000
Review: 71 days
Class: Class II
Product code: DBI
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K780913 (1978). 2 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK780913 Additional Reagents Kits for Imm. SystemBeckman Instruments, Inc. · 1978
This deviceK994293 Dimension C4 Flex Reagent CartridgeDade Behring, Inc. · 2000

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K780913	Additional Reagents Kits for Imm. System	Beckman Instruments, Inc.	1978	—
0 (this device)	K994293	Dimension C4 Flex Reagent Cartridge	Dade Behring, Inc.	2000	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1992	1	0

FIG. 1 — Lineage of K994293, 1978–2000Source: 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 DBI? 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? (2)

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
*	K780913	Additional Reagents Kits for Imm. System Summary page 1 …e of Product: C4 Flex® Reagent Cartridge FDA Classification Name: Complement C4, Antigen, Antiserum, Control; 82CZW Predicate Device: Beckman Array® Complement C4 Assay (K780913; K922273) Device Description: The C4 Flex® reagent cartridge for the Dimension® clinical chemistry system is a quantitative, tur…	Beckman Instruments, Inc.	1978	—
*	K922273	Array (R) 360 Summary page 1 …uct: C4 Flex® Reagent Cartridge FDA Classification Name: Complement C4, Antigen, Antiserum, Control; 82CZW Predicate Device: Beckman Array® Complement C4 Assay (K780913; K922273) Device Description: The C4 Flex® reagent cartridge for the Dimension® clinical chemistry system is a quantitative, turbidimetri…	Beckman Instruments, Inc.	1992	—

Also cleared against K780913: 6 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?

None of the 2 ancestors has a recall.
6 other devices also cite its predicate K780913.

How does its category compare?

All DBI devices

DBI Complement C4, Antigen, Antiserum, Control: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DBI

1in 2010

2007high 1 (2010) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DBI

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

Recalls per year · DBI

1in 2020

2007high 1 (2020) · low 0 (2007)2026

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

Adverse event reports per year · DBI

1in 2024

2007high 1 (2024) · low 0 (2007)2025

MAUDE reports naming product code DBI, 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	0	—	0	0
2010	1	—	0	0
2011	0	—	0	0
2012	0	—	0	0
2013	0	—	0	0
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	—	1	0
2021	0	—	0	0
2022	0	—	0	0
2023	0	—	0	0
2024	0	—	0	1
2025	0	—	0	0
2026	0	—	0	—

What is it indicated for?

The C4 Flex® reagent cartridge for the Dimension® clinical chemistry system is an in vitro diagnostic test intended to quantitatively measure complement C4 (C4) in serum as an aid in the diagnosis of immunologic disorders associated with complement C4 protein.

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/K994293 · printed Nov 6, 2026

Cite this page

510(k) Report. “K994293: Dimension C4 Flex Reagent Cartridge.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K994293

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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