510(k) · Cleared
ClearedOlympus Igg Immunoturbidimetric Reagent
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus America, Inc. · CFQ Radioimmunoassay, Immunoglobulins (G, A, M)
Cleared on Apr 17, 1995 after a 42-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 4 later devices descend from it.
- Decided
- Apr 17, 1995
- Review
- 42 days
- Class
- Class II
- Product code
- CFQ
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 1 citing it directly.
- This deviceK951013 Olympus Igg Immunoturbidimetric ReagentOlympus America, Inc. · 1995
- Descendant · cites it directly · 3 of its ownK073490 Olympus Igg ReagentOlympus America, Inc. · 2008
- Descendant · 2 generations on · 1 of its ownK162208 DxC 700 AU Clinical Chemistry Analyzer, AU IgG ReagentBeckman Coulter, Inc. · 2017
- Descendant · 3 generations on · 0 of its ownK221114 Immunoglobulin G (IgG)Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. · 2023
- Descendant · 2 generations on · 0 of its ownK193525 Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G…Horiba Abx Sas · 2020
Most influential descendants
Showing 4 of 4 · See all- K073490Olympus Igg ReagentOlympus America, Inc. · 2008 · cites it directly3descendants
- K162208DxC 700 AU Clinical Chemistry Analyzer, AU IgG ReagentBeckman Coulter, Inc. · 2017 · 2 generations on1descendant
- K221114Immunoglobulin G (IgG)Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. · 2023 · 3 generations on0descendants
- K193525Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200…Horiba Abx Sas · 2020 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K951013 | Olympus Igg Immunoturbidimetric Reagent | Olympus America, Inc. | 1995 | — |
| +1 | K073490 | Olympus Igg Reagent | Olympus America, Inc. | 2008 | — |
| +2 | K162208 | DxC 700 AU Clinical Chemistry Analyzer, AU IgG Reagent | Beckman Coulter, Inc. | 2017 | — |
| +3 | K221114 | Immunoglobulin G (IgG) | Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. | 2023 | — |
| +2 | 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 |
|---|---|---|
| 2008 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in CFQ? 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K073490 | Olympus Igg Reagent | 2008 | 3 |
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, K073490 (Olympus America, Inc., 2008) has gone furthest, with 3 descendants of its own.
How does its category compare?
All CFQ devicesCFQ Radioimmunoassay, Immunoglobulins (G, A, M): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CFQ
FDA has decided no CFQ device since 2007.
Median 510(k) review, days · CFQ
Too few CFQ 510(k)s in any year since 2007 to give a median.
Recalls per year · CFQ
No recall names CFQ since 2007.
Adverse event reports per year · CFQ
1in 2018
MAUDE reports naming product code CFQ, 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 | 1 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 3 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K951013 · printed Nov 6, 2026
Cite this page
510(k) Report. “K951013: Olympus Igg Immunoturbidimetric Reagent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K951013
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026