510(k) · Cleared

Recalled · Class II · 2017

Ferritin on the Access Immunoassay Systems, Model 33020

K052082510(k) SpecialCleared Aug 19, 200517-day reviewClass II21 CFR 866.5340Recalls 1

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

Beckman Coulter, Inc. · JMG Radioimmunoassay (Two-Site Solid Phase), Ferritin

Cleared on Aug 19, 2005 as substantially equivalent to K926221 (Bio-Rad Laboratories, Inc., 1993) after a 17-day review. Its family tree reaches back 1 generation to 1993. 1 later device descends from it. It has been recalled once.

Decided: Aug 19, 2005
Review: 17 days
Class: Class II
Product code: JMG
Recalls: 1
Predicates: 1

Its longest line of descent runs back 1 generation to K926221 (1993). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK926221 Access Ferritin AssayBio-Rad Laboratories, Inc. · 1993 · Recalled
This deviceK052082 Ferritin on the Access Immunoassay Systems, Model 33020Beckman Coulter, Inc. · 2005
Descendant · cites it directly · 0 of its ownK234052 Access FerritinBeckman Coulter, Inc. · 2024

Most influential descendants

Showing 1 of 1 · See all

K234052Access FerritinBeckman Coulter, Inc. · 2024 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K926221	Access Ferritin Assay	Bio-Rad Laboratories, Inc.	1993	1
0 (this device)	K052082	Ferritin on the Access Immunoassay Systems, Model 33020	Beckman Coulter, Inc.	2005	—
+1	K234052	Access Ferritin	Beckman Coulter, Inc.	2024	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2024	1	0

FIG. 1 — Lineage of K052082, 1993–2024Source: 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 JMG? 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 JMG device

#1 K234052 Access Ferritinscore 7.3 · 2 generations · no Class I recall

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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
*	K926221	Access Ferritin Assay Summary page 1 …Enzyme Immunoassay, Ferritin Predicate Device Access Ferritin Assay Beckman Coulter, Inc. 1000 Lake Hazeltine Drive Chaska, MN 55318 510(k) Number: K926221 Beckman Coulter, Inc. Telephone: (952) 448-4848 1000 Lake Hazeltine Drive Internet: www~beck…	Bio-Rad Laboratories, Inc.	1993	1

Also cleared against K926221: 4 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
K234052	Access Ferritin	Beckman Coulter, Inc.	2024	0

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Mar 10, 2017	Class II	Z-1833-2017	Other	Beckman Coulter is recalling the Access Ferritin Calibrators kit because it contains a calibration card with an incorrect S5 calibrator concentration.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has a recall.
Of its descendants, K234052 (Beckman Coulter, Inc., 2024) has gone furthest, with 0 descendants of its own.
4 other devices also cite its predicate K926221.

How does its category compare?

All JMG devices

JMG Radioimmunoassay (Two-Site Solid Phase), Ferritin: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JMG

1in 2024

2007high 1 (2024) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JMG

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

Recalls per year · JMG

1in 2025

2007high 1 (2013) · low 0 (2007)2026

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

Adverse event reports per year · JMG

12in 2025

2007high 13 (2023) · low 0 (2007)2025

MAUDE reports naming product code JMG, 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	0	—	0	1
2011	0	—	0	0
2012	0	—	0	0
2013	0	—	1	12
2014	0	—	0	2
2015	0	—	0	0
2016	0	—	0	1
2017	0	—	0	1
2018	0	—	0	3
2019	0	—	0	1
2020	0	—	0	4
2021	0	—	0	5
2022	0	—	0	2
2023	0	—	0	13
2024	1	—	0	11
2025	0	—	1	12
2026	0	—	0	—

What is it indicated for?

The Access Ferritin assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of ferritin levels in human serum and plasma (heparin) using the Access Immunoassay Systems.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K052082 · printed Nov 6, 2026

Cite this page

510(k) Report. “K052082: Ferritin on the Access Immunoassay Systems, Model 33020.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052082

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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