510(k) · Cleared
ClearedAia-Pack Iri
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tosoh Corp. · CFP Radioimmunoassay, Immunoreactive Insulin
Cleared on Sep 7, 1990 after a 28-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it.
- Decided
- Sep 7, 1990
- Review
- 28 days
- Class
- Class I
- Product code
- CFP
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 1 citing it directly.
- This deviceK903628 Aia-Pack IriTosoh Corp. · 1990
- Descendant · cites it directly · 3 of its ownK021535 Advia Cantaur and Acs:180 Insulin CalibratorBayer Diagnostics Corp. · 2002 · Recalled
- Descendant · 2 generations on · 1 of its ownK060359 Archiect Insulin and Controls, Model 8K41-01, 8K41-10Denka Seiken Co., Ltd. · 2006
- Descendant · 3 generations on · 0 of its ownK171168 VITROS Immunodiagnostic Products Insulin CalibratorsOrtho Clinical Diagnostics · 2017
- Descendant · 2 generations on · 0 of its ownK162538 ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA…Siemens Healthcare Diagnostics · 2016
Most influential descendants
Showing 4 of 4 · See all- K021535Advia Cantaur and Acs:180 Insulin CalibratorBayer Diagnostics Corp. · 2002 · cites it directly3descendants
- K060359Archiect Insulin and Controls, Model 8K41-01, 8K41-10Denka Seiken Co., Ltd. · 2006 · 2 generations on1descendant
- K171168VITROS Immunodiagnostic Products Insulin CalibratorsOrtho Clinical Diagnostics · 2017 · 3 generations on0descendants
- K162538ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI) CalibratorSiemens Healthcare Diagnostics · 2016 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K903628 | Aia-Pack Iri | Tosoh Corp. | 1990 | — |
| +1 | K021535 | Advia Cantaur and Acs:180 Insulin Calibrator | Bayer Diagnostics Corp. | 2002 | 2 |
| +2 | K060359 | Archiect Insulin and Controls, Model 8K41-01, 8K41-10 | Denka Seiken Co., Ltd. | 2006 | — |
| +3 | K171168 | VITROS Immunodiagnostic Products Insulin Calibrators | Ortho Clinical Diagnostics | 2017 | — |
| +2 | K162538 | ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI)… | Siemens Healthcare Diagnostics | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2006 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 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 CFP? 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 has not posted a summary or statement for it, 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 |
|---|---|---|---|
| K021535 | Advia Cantaur and Acs:180 Insulin Calibrator | 2002 | 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, K021535 (Bayer Diagnostics Corp., 2002) has gone furthest, with 3 descendants of its own.
How does its category compare?
All CFP devicesCFP Radioimmunoassay, Immunoreactive Insulin: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CFP
FDA has decided no CFP device since 2007.
Median 510(k) review, days · CFP
Too few CFP 510(k)s in any year since 2007 to give a median.
Recalls per year · CFP
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CFP
17in 2025
MAUDE reports naming product code CFP, 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 | — | 1 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 2 |
| 2012 | 0 | — | 2 | 8 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 2 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 3 |
| 2017 | 0 | — | 0 | 4 |
| 2018 | 0 | — | 0 | 4 |
| 2019 | 0 | — | 0 | 9 |
| 2020 | 0 | — | 0 | 6 |
| 2021 | 0 | — | 0 | 10 |
| 2022 | 0 | — | 0 | 7 |
| 2023 | 0 | — | 1 | 10 |
| 2024 | 0 | — | 1 | 7 |
| 2025 | 0 | — | 0 | 17 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K903628 · printed Nov 5, 2026
Cite this page
510(k) Report. “K903628: Aia-Pack Iri.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K903628
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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