510(k) · Cleared
ClearedAtac Pak Phosphorus Reagent
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Elan Diagnostics · CEO Phosphomolybdate (Colorimetric), Inorganic Phosphorus
Cleared on Mar 7, 2003 after a 64-day review. The FDA summary names its predicate without a number.
- Decided
- Mar 7, 2003
- Review
- 64 days
- Class
- Class I
- Product code
- CEO
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
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 CEO? 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 |
|---|---|---|---|
| * | — | Beckman Synchron Phosphorus Reagent, product 465 145 Named without a submission number |
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.
How does its category compare?
All CEO devicesCEO Phosphomolybdate (Colorimetric), Inorganic Phosphorus: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CEO
1in 2011
2026 to Oct 25, outlined.
Median 510(k) review, days · CEO
Too few CEO 510(k)s in any year since 2007 to give a median.
Recalls per year · CEO
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CEO
8in 2025
MAUDE reports naming product code CEO, 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 | 13 |
| 2008 | 1 | — | 0 | 1 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 1 | 41 |
| 2011 | 1 | — | 0 | 19 |
| 2012 | 0 | — | 1 | 0 |
| 2013 | 0 | — | 3 | 1 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 3 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 4 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 0 | — | 0 | 2 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 0 | — | 0 | 3 |
| 2022 | 0 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 5 |
| 2024 | 0 | — | 0 | 5 |
| 2025 | 0 | — | 1 | 8 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The ATAC PAK Phosphorus Reagent Kit is intended for use with the ATAC Calibrator and the ATAC 8000 Random Access Chemistry System as a system for the quantitative determination of inorganic phosphorus in serum and plasma. Phosphorus results are used for the diagnosis and treatment of various disorders, including parathyroid gland and kidney diseases, and vitamin D imbalance.
This reagent is intended to be used by trained personnel in a professional setting and is not intended for home use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030015 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030015: Atac Pak Phosphorus Reagent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030015
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026