510(k) · Cleared
ClearedDeroyal Technologices, Inc. Liquid Crystal Skin Temperature Strip
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Deroyal Critical Care, Div. Deroyal Technologies · FQZ Thermometer, Clinical Color Change
Cleared on Jul 19, 1995 after a 219-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
- Decided
- Jul 19, 1995
- Review
- 219 days
- Class
- Class I
- Product code
- FQZ
- Recalls
- None
- Predicates
- 0
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FQZ? 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
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 FQZ devicesFQZ Thermometer, Clinical Color Change: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FQZ
1in 2012
2026 to Oct 25, outlined.
Median 510(k) review, days · FQZ
Too few FQZ 510(k)s in any year since 2007 to give a median.
Recalls per year · FQZ
No recall names FQZ since 2007.
Adverse event reports per year · FQZ
2in 2023
MAUDE reports naming product code FQZ, 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 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K946046 · printed Nov 5, 2026
Cite this page
510(k) Report. “K946046: Deroyal Technologices, Inc. Liquid Crystal Skin Temperature Strip.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K946046
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026