510(k) · Cleared
Recalled · Class II · 2013Aia Nexia-Automated Enzyme Immunoassay System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tosoh Medics, Inc. · KHO Fluorometer, For Clinical Use
Cleared on Jun 27, 1997 after a 93-day review. FDA’s file for it is a 510(k) statement, which names no predicate. It has been recalled 2 times.
- Decided
- Jun 27, 1997
- Review
- 93 days
- Class
- Class I
- Product code
- KHO
- Recalls
- 2
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KHO? 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’s file for it is a 510(k) statement, which names no predicate.
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 |
|---|---|---|---|---|
| May 15, 2013 | Class II | Z-1830-2013 | Nonconforming Material/Component | Visual inspection of the pipette tips indicated that some of the tips were not uniform in size/length which was causing error messages on the analyzers. |
| Apr 2, 2003 | Not classified | Z-0218-05 | Other | A software upgrade was released by the firm for its AIA-600 II analyzers, in that washing deficiencies caused by the analyzer were corrected. |
No ancestor or descendant has a Class I recall.
How does its category compare?
All KHO devicesKHO Fluorometer, For Clinical Use: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KHO
1in 2012
2026 to Oct 25, outlined.
Median 510(k) review, days · KHO
Too few KHO 510(k)s in any year since 2007 to give a median.
Recalls per year · KHO
7in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KHO
178in 2025
MAUDE reports naming product code KHO, 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 | 5 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 0 | — | 0 | 24 |
| 2010 | 0 | — | 0 | 49 |
| 2011 | 0 | — | 2 | 29 |
| 2012 | 1 | — | 1 | 68 |
| 2013 | 0 | — | 0 | 53 |
| 2014 | 0 | — | 2 | 65 |
| 2015 | 0 | — | 0 | 30 |
| 2016 | 0 | — | 0 | 35 |
| 2017 | 0 | — | 4 | 152 |
| 2018 | 0 | — | 7 | 2,123 |
| 2019 | 0 | — | 0 | 440 |
| 2020 | 0 | — | 0 | 257 |
| 2021 | 0 | — | 0 | 213 |
| 2022 | 0 | — | 0 | 224 |
| 2023 | 0 | — | 0 | 260 |
| 2024 | 0 | — | 0 | 168 |
| 2025 | 0 | — | 0 | 178 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The AIA NexIA Automated Enzyme Immunoassay System is a combination device, utilizing a fluorometer and automated pipettor, intended for clinical use. The NexIA is used in conjunction with the AIA-PACK reagent series to measure a variety of analytes in biological fluids which aid in the diagnosis and treatment of various disorders.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K971103 · printed Nov 6, 2026
Cite this page
510(k) Report. “K971103: Aia Nexia-Automated Enzyme Immunoassay System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K971103
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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