510(k) · Cleared
Recalled · Class II · 2024Olympus Igm Reagent
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus America, Inc. · CFN Method, Nephelometric, Immunoglobulins (G, A, M)
Cleared on Feb 11, 2008 as substantially equivalent to K950900 (Olympus America, Inc., 1995) after a 61-day review. Its family tree reaches back 1 generation to 1995. 1 later device descends from it. It has been recalled once.
- Decided
- Feb 11, 2008
- Review
- 61 days
- Class
- Class II
- Product code
- CFN
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K950900 (1995). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK950900 Olympus Igm Immunoturbidimetric ReagentOlympus America, Inc. · 1995
- This deviceK073487 Olympus Igm ReagentOlympus America, Inc. · 2008
- Descendant · cites it directly · 0 of its ownK193525 Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G…Horiba Abx Sas · 2020
Most influential descendants
Showing 1 of 1 · See all- K193525Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200…Horiba Abx Sas · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K950900 | Olympus Igm Immunoturbidimetric Reagent | Olympus America, Inc. | 1995 | — |
| 0 (this device) | K073487 | Olympus Igm Reagent | Olympus America, Inc. | 2008 | — |
| +1 | K193525 | Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200… | Horiba Abx Sas | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
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 CFN? 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 CFN device
- #1 K233663 N Antisera to Human Immunoglobulins (IgG, IgA…score 8.3 · 7 generations · no Class I recall
- #2 Held for the reportin 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 |
|---|---|---|---|
| * | K950900 | Olympus Igm Immunoturbidimetric ReagentSummary page 1…control. 3. Predicate device Reagent: Olympus (OSR6X46) IgM Reagent Submitted K950900 4. Device description In this Olympus procedure: * When a sample is mixed with RI… | 1995 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K193525 | Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200… | 2020 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 27, 2024 | Class II | Z-2428-2024 | Process control | LIH Influence check settings for Lipemia are incorrect which may result patient samples being reported as false low results or cause a high result to report as normal |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K193525 (Horiba Abx Sas, 2020) has gone furthest, with 0 descendants of its own.
How does its category compare?
All CFN devicesCFN Method, Nephelometric, Immunoglobulins (G, A, M): FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · CFN
2in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · CFN
28in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CFN
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CFN
1in 2024
MAUDE reports naming product code CFN, 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 | 7 | 69 | 0 | 0 |
| 2009 | 4 | 160 | 0 | 0 |
| 2010 | 2 | — | 0 | 3 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 3 |
| 2013 | 4 | 431 | 0 | 0 |
| 2014 | 2 | — | 5 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 2 |
| 2017 | 1 | — | 0 | 4 |
| 2018 | 0 | — | 2 | 2 |
| 2019 | 6 | 28 | 0 | 8 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 2 | 1 |
| 2023 | 2 | — | 1 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
System reagent for the quantitative determination of IgM immunoglobulins in human serum and plasma on OLYMPUS analyzers.
The spectrum of abnormalities in serum immunoglobulin concentrations is broad. Abnormal concentrations range from a virtual absence of one or more of the three major classes of immunoglobulin (IgA, IgG, and IgM) to polyclonal increases in one or more immunoglobulins. Measurement of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.
For in vitro diagnostic use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073487 · printed Nov 4, 2026
Cite this page
510(k) Report. “K073487: Olympus Igm Reagent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K073487
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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