De Novo · Granted
GrantedPainChek (PainChek Adult)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Painchek Limited (Ltd.) · SGB Pain Assessment Software In Non-Communicative Adults
Granted on Oct 6, 2025 as a new device type through De Novo after a 299-day review.
- Decided
- Oct 6, 2025
- Review
- 299 days
- Class
- Class II
- Product code
- SGB
- Recalls
- None
De Novo grants create a new device type without a predicate, so this family tree starts here.
Sources: FDA De Novo 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 SGB? 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
Does it have a predicate?
De Novo decisions do not claim a predicate device.
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 SGB devicesSGB Pain Assessment Software In Non-Communicative Adults: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · SGB
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · SGB
Too few SGB 510(k)s in any year since 2007 to give a median.
Recalls per year · SGB
No recall names SGB since 2007.
Adverse event reports per year · SGB
No MAUDE report names SGB 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 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 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 | — |
What is it indicated for?
PainChek Adult is an observational pain assessment software application used to assist healthcare professionals in the assessment of pain in non-verbal patients who have been diagnosed with moderate to severe dementia and who are living in nursing homes. Specifically, PainChek Adult is intended to be used by trained medical doctors, nurses, licensed practical and vocational nurses, certified nursing assistants, clinical psychologists, physical therapists and occupational therapists to assess pain in the indicated population.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN240073 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN240073: PainChek (PainChek Adult).” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN240073
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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