510(k) · Cleared
ClearedXtender Film Processor, Sprint Film Processor Model Xtender Model Sprint
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 Aug 18, 2011 as substantially equivalent to K093503 (Velopex International, Inc., 2010) and 1 other predicate after a 114-day review. Its family tree reaches back 2 generations to 1987.
- Decided
- Aug 18, 2011
- Review
- 114 days
- Class
- Class II
- Product code
- IXW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K874118 (1987). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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? (6)
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 |
|---|---|---|---|
| * | K093503 | Intrax Film ProcessorSummary page 1…ic-Film, Automatic > Device Class 2 > Regulation Number; 892.1900 Legally marketed device to which we are claiming equivalence: > Velopex IntraX Film Processor #K093503 > Air Techniques Inc. (Registered Establishment # 2428225) A/T 2000 Automatic Film Processor > Dent-X Co., Model 41… | 2010 |
| * | K874118 | Model 410 Dental X-Ray Film ProcessorsSummary page 1…#K093503 > Air Techniques Inc. (Registered Establishment # 2428225) A/T 2000 Automatic Film Processor > Dent-X Co., Model 410 Dental X-Ray Film Processor #K874118 > Air Techniques Inc. (Registered Establishment##2428225) Pen-Pro Film Processor > Air Techniques Inc. (Registered… | 1987 |
| * | — | Air Techniques Inc. A/T 2000 Automatic Film Processor Named without a submission number | |
| * | — | Air Techniques Inc. Pen-Pro Film Processor Named without a submission number | |
| * | — | Air Techniques Inc. All-Pro 2010 Film Processor Named without a submission number | |
| * | — | Air Techniques Inc. All-Pro 100 Plus Film Processor Named without a submission 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.
What does this lineage say?
- The line of descent spans 24 years and passes through 2 companies; a new generation was cleared every 22.2 years on median.
- None of the 2 ancestors has a recall.
How does its category compare?
All IXW devicesIXW Processor, Radiographic-Film, Automatic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 | — |
https://510kreport.com/device/K111167 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111167: Xtender Film Processor, Sprint Film Processor Model Xtender Model Sprint.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111167
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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