510(k) · Cleared
ClearedFORA MD6 Uric Acid Monitoring System, FORA MD6 Pro Uric Acid Monitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Taidoc Technology Corporation · PTC Uric Acid Test System For At Home Prescription Use
Cleared on Dec 10, 2018 after a 168-day review. The FDA summary names no predicate by number.
- Decided
- Dec 10, 2018
- Review
- 168 days
- Class
- Class I
- Product code
- PTC
- Recalls
- None
- Predicates
- 0
The FDA summary names no predicate by 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 PTC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new PTC device
- #1 K242209 UASure II Blood Uric Acid Monitoring Systemscore 9.4 · 2 generations · no Class I recall
What was it cleared against?
The FDA summary names no predicate by 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 PTC devicesPTC Uric Acid Test System For At Home Prescription Use: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · PTC
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PTC
Too few PTC 510(k)s in any year since 2007 to give a median.
Recalls per year · PTC
No recall names PTC since 2007.
Adverse event reports per year · PTC
No MAUDE report names PTC since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K181675 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181675: FORA MD6 Uric Acid Monitoring System, FORA MD6 Pro Uric Acid Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181675
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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