510(k) · Cleared
ClearedPHOS
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 12, 1998 as substantially equivalent to K883962 (Roche Diagnostic Systems, Inc., 1988) and 1 other predicate after a 77-day review. Its family tree reaches back 1 generation to 1987.
- Decided
- Jun 12, 1998
- Review
- 77 days
- Class
- Class I
- Product code
- CEO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K872494 (1987). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK872494 Hitachi 717 Chemistry AnalyzerBoehringer Mannheim Corp. · 1987
- This deviceK981118 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) | K981118 | PHOS | Abbott Laboratories | 1998 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 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 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? (2)
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 |
|---|---|---|---|
| * | K883962 | Roche Reagent for Inorganic PhosphorusSummary page 1…ic phosphorus present. Substantial Equivalence: The Phosphorus assay is substantially equivalent to the following devices: « Roche® Cobas Mira® Plus Phosphorus assay (K883962) for the serum application + Boehringer Mannheim® Phosphorus Assay (K872494) on the Hitachi® 717 Analyzer for the urine applica… | 1988 |
| * | K872494 | Hitachi 717 Chemistry AnalyzerSummary page 1…stantially equivalent to the following devices: « Roche® Cobas Mira® Plus Phosphorus assay (K883962) for the serum application + Boehringer Mannheim® Phosphorus Assay (K872494) on the Hitachi® 717 Analyzer for the urine application Phosphorus 510(k) Section I1 March 26, 1998 Page 1 Phos326.1wp 0000012… | 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 2 ancestors has a recall.
- 3 other devices also cite its predicate K883962.
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.
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/K981118 · printed Nov 4, 2026
Cite this page
510(k) Report. “K981118: PHOS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K981118
Report an extraction error
Are you the manufacturer?
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