510(k) · Cleared
ClearedIntrax Film Processor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Velopex International, Inc. · IXW Processor, Radiographic-Film, Automatic
Cleared on Jan 6, 2010 as substantially equivalent to K874118 (Dent-X Co., 1987) after a 55-day review. Its family tree reaches back 1 generation to 1987. 1 later device descends from it.
- Decided
- Jan 6, 2010
- Review
- 55 days
- Class
- Class II
- Product code
- IXW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K874118 (1987). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK874118 Model 410 Dental X-Ray Film ProcessorsDent-X Co. · 1987
- This deviceK093503 Intrax Film ProcessorVelopex International, Inc. · 2010
- Descendant · cites it directly · 0 of its ownK111167 Xtender Film Processor, Sprint Film Processor Model Xtender Model…Velopex International, Inc. · 2011
Most influential descendants
Showing 1 of 1 · See all- K111167Xtender Film Processor, Sprint Film Processor Model Xtender Model SprintVelopex International, Inc. · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K874118 | Model 410 Dental X-Ray Film Processors | Dent-X Co. | 1987 | — |
| 0 (this device) | K093503 | Intrax Film Processor | Velopex International, Inc. | 2010 | — |
| +1 | K111167 | Xtender Film Processor, Sprint Film Processor Model Xtender Model Sprint | Velopex International, Inc. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
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 IXW? 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? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K874118 | Model 410 Dental X-Ray Film ProcessorsSummary page 1…Processor > Air Techniques Inc. (Registered Establishment # 2425225) A/T 2000 Automatic Film Processor > Dent-X Co., Model 410 Dental X-Ray Film Processor #K874118 4 DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Ser vice… | 1987 |
| * | — | Peni-Pro Film Processor Named without a submission number | |
| * | — | A/T 2000 Automatic Film Processor Named without a submission number |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K111167 | Xtender Film Processor, Sprint Film Processor Model Xtender Model Sprint | 2011 | 0 |
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?
How does its category compare?
All IXW devicesIXW Processor, Radiographic-Film, Automatic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · IXW
1in 2011
2026 to Oct 25, outlined.
Median 510(k) review, days · IXW
Too few IXW 510(k)s in any year since 2007 to give a median.
Recalls per year · IXW
No recall names IXW since 2007.
Adverse event reports per year · IXW
2in 2018
MAUDE reports naming product code IXW, 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 | 1 |
| 2009 | 1 | — | 0 | 2 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 2 |
| 2015 | 0 | — | 0 | 2 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 2 |
| 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 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The IntraX Film Processor is an automatic processor used by dental offices to develop intraoral films. It processes all sizes of intraoral film.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093503 · printed Nov 5, 2026
Cite this page
510(k) Report. “K093503: Intrax Film Processor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K093503
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