510(k) · Cleared
ClearedLumos, Model R 72B
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lumos, Inc. · KPW Device, Beam Limiting, X-Ray, Diagnostic
Cleared on Jan 12, 2010 as substantially equivalent to K030487 (Ralco S.R.L., 2003) after a 53-day review. Its family tree reaches back 2 generations to 1995.
- Decided
- Jan 12, 2010
- Review
- 53 days
- Class
- Class II
- Product code
- KPW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K946320 (1995). 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 KPW? 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? (1)
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 |
|---|---|---|---|
| * | K030487 | R 72Summary page 1…diographic, Product Code KPW Common[Usual Name: Manual X-Ray Collimator. 2. Equivalent legally marketed devices: This device is IDENTICAL to the Ralco Model R72 (K030487). This submission sets a baseline for Lumnos Inc. to manufacture and control te desig of the collimator shown in K030487..… | 2003 |
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 15 years and passes through 2 companies; a new generation was cleared every 8.2 years on median.
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K030487.
How does its category compare?
All KPW devicesKPW Device, Beam Limiting, X-Ray, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · KPW
1in 2010
2026 to Oct 25, outlined.
Median 510(k) review, days · KPW
Too few KPW 510(k)s in any year since 2007 to give a median.
Recalls per year · KPW
No recall names KPW since 2007.
Adverse event reports per year · KPW
1in 2014
MAUDE reports naming product code KPW, 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 | 1 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 1 |
| 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 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Model R 72B Manual X-RAY Collimator is intended for use in diagnostic radiographic or fluoroscopic applications.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093596 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093596: Lumos, Model R 72B.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093596
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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