510(k) · Cleared
ClearedIRON
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Laboratories · CFM Bathophenanthroline, Colorimetry, Iron (Non-Heme)
Cleared on Jun 8, 1998 as substantially equivalent to K854298 (Boehringer Mannheim Corp., 1985) after a 35-day review. Its family tree reaches back 1 generation to 1985.
- Decided
- Jun 8, 1998
- Review
- 35 days
- Class
- Class I
- Product code
- CFM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K854298 (1985). No later device cites it as a predicate yet.
- Root · 1 generation backK854298 IRONBoehringer Mannheim Corp. · 1985
- This deviceK981581 IRONAbbott Laboratories · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K854298 | IRON | Boehringer Mannheim Corp. | 1985 | — |
| 0 (this device) | K981581 | IRON | Abbott Laboratories | 1998 | — |
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 CFM? 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
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 | Decided |
|---|---|---|---|
| * | K854298 | IRONSummary page 1…and turbidity, respectively. Substantial Equivalence: The Iron assay is substantially equivalent to the Boehringer Mannheim® Iron assay on the Hitachi® 717 Analyzer (K854298). Iron 510¢k) Section II May 1, 1998 Page 1 Ironfiwp 00C0011 ........ Both assay yield similar Performance Cha… | 1985 |
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?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K854298.
How does its category compare?
All CFM devicesCFM Bathophenanthroline, Colorimetry, Iron (Non-Heme): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CFM
FDA has decided no CFM device since 2007.
Median 510(k) review, days · CFM
Too few CFM 510(k)s in any year since 2007 to give a median.
Recalls per year · CFM
No recall names CFM since 2007.
Adverse event reports per year · CFM
1in 2023
MAUDE reports naming product code CFM, 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 | 9 |
| 2008 | 0 | — | 0 | 6 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 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 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Iron assay is used for the quantitation of iron in human serum. Iron (non-heme) measurements are used in the diagnosis and treatment of diseases such as iron deficiency anemia, hemochromatosis (a disease associated with widespread deposit in the tissues of two iron-containing pigments, hemosiderin and hemofuscin, and characterized by pigmentation of the skin), and chronic renal disease.
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/K981581 · printed Nov 6, 2026
Cite this page
510(k) Report. “K981581: IRON.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K981581
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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