De Novo · Granted
GrantedAccuMeasure System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
RQMIS, Inc. · QTH Endoscopic Light-Projecting Measuring Device
Granted on Jul 26, 2022 as a new device type through De Novo after a 351-day review. 2 later devices descend from it.
- Decided
- Jul 26, 2022
- Review
- 351 days
- Class
- Class II
- Product code
- QTH
- Recalls
- None
2 later devices descend from it, 1 citing it directly.
- This deviceDEN210032 AccuMeasure SystemRQMIS, Inc. · 2022
- Descendant · cites it directly · 1 of its ownK223827 FUJIFILM Endoscope Model EC-760S-A/L, Endoscopy Support Program…Fujifilm Corporation · 2023
- Descendant · 2 generations on · 0 of its ownK261880 FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscopy…Fujifilm Corporation · 2026
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN210032 | AccuMeasure System | RQMIS, Inc. | 2022 | — |
| +1 | K223827 | FUJIFILM Endoscope Model EC-760S-A/L, Endoscopy Support Program EW10-VM01 | Fujifilm Corporation | 2023 | — |
| +2 | K261880 | FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscopy Support Program… | Fujifilm Corporation | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2026 | 1 | 0 |
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 QTH? 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? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K223827 | FUJIFILM Endoscope Model EC-760S-A/L, Endoscopy Support Program EW10-VM01 | 2023 | 1 |
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?
- Of its descendants, K223827 (Fujifilm Corporation, 2023) has gone furthest, with 1 descendant of its own.
How does its category compare?
All QTH devicesQTH Endoscopic Light-Projecting Measuring Device: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · QTH
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · QTH
Too few QTH 510(k)s in any year since 2007 to give a median.
Recalls per year · QTH
No recall names QTH since 2007.
Adverse event reports per year · QTH
No MAUDE report names QTH 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 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The AccuMeasure System is intended to be used as an accessory in conjunction with an endoscope to measure observable anatomy and pathology in the gastrointestinal tract. The AccuMeasure System provides no therapeutic or diagnostic function.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN210032 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN210032: AccuMeasure System.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN210032
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