510(k) · Cleared
Recalled · Class II · 2013PHOS
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Laboratories · CEO Phosphomolybdate (Colorimetric), Inorganic Phosphorus
Cleared on Jun 16, 1998 as substantially equivalent to K872494 (Boehringer Mannheim Corp., 1987) after a 28-day review. Its family tree reaches back 1 generation to 1987. It has been recalled 2 times.
- Decided
- Jun 16, 1998
- Review
- 28 days
- Class
- Class I
- Product code
- CEO
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 1 generation to K872494 (1987). No later device cites it as a predicate yet.
- Root · 1 generation backK872494 Hitachi 717 Chemistry AnalyzerBoehringer Mannheim Corp. · 1987
- This deviceK981759 PHOSAbbott Laboratories · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K872494 | Hitachi 717 Chemistry Analyzer | Boehringer Mannheim Corp. | 1987 | — |
| 0 (this device) | K981759 | PHOS | 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 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 |
|---|---|---|---|
| * | K872494 | Hitachi 717 Chemistry AnalyzerSummary page 1…orus present in the sample. Substantial Equivalence: The Phosphorus assay is substantially equivalent to the following devices: Boehringer Mannheim® Phosphorus Assay (K872494) on the Hitachi® 717 Analyzer Phosphorus 510(k) Section II May 18, 1998 Page 1 Phos.lwp 0000014 R ~~~~~~ The… | 1987 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 12, 2013 | Class II | Z-0020-2014 | Error in labeling | Reagent lots 64736UN12, 03991UN13, 51611UN13, 74805UN12, and 03992UN13 have incorrect expiration dates assigned by Supplier. |
| Jan 30, 2007 | Not classified | Z-0722-2007 | Other | Patient results are falsely decreased by up to 15% at these levels: 1) Serum Plasma phosphorus greater than 8.0 mg/dL (2.60 mmol/L) 2) Urine phosphorus greater than 80.0 mg/dL (25.80 mmol/L) |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- 4 other devices also cite its predicate K872494.
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 Phosphorus assay is used for the quantitation of inorganic phosphorus in human serum, plasma, or urine. Measurements of phosphorus (inorganic) are used in the diagnosis and treatment of various disorders, including parathyroid gland and kidney diseases, and vitamin D imbalance.
The Phosphorus assay is used for the quantitation of inorganic phosphorus in human serum, plasma, or urine. Measurements of phosphorus (inorganic) are used in the diagnosis and treatment of various disorders, including parathyroid gland and kidney diseases, and vitamin D imbalance.
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/K981759 · printed Nov 6, 2026
Cite this page
510(k) Report. “K981759: PHOS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K981759
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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