510(k) · Cleared
ClearedR 72
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ralco S.R.L. · KPW Device, Beam Limiting, X-Ray, Diagnostic
Cleared on Aug 1, 2003 as substantially equivalent to K946320 (Ralco S.R.L., 1995) after a 168-day review. Its family tree reaches back 1 generation to 1995. 2 later devices descend from it.
- Decided
- Aug 1, 2003
- Review
- 168 days
- Class
- Class II
- Product code
- KPW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K946320 (1995). 2 later devices descend from it, 2 citing it directly.
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 |
|---|---|---|---|---|---|
| −1 | K946320 | R 302 | Ralco S.R.L. | 1995 | — |
| 0 (this device) | K030487 | R 72 | Ralco S.R.L. | 2003 | — |
| +1 | K110856 | RALCO | Ralco S.R.L. | 2011 | — |
| +1 | K093596 | Lumos, Model R 72B | Lumos, Inc. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 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 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 |
|---|---|---|---|
| * | K946320 | R 302Summary page 1…: COLLIMATOR, MANUAL, RADIOGRAPHIC, Product Code IZX CommodUsual Name: Manually Operated X-Ray Collimator. 2. Equivalent legally marketed devices: Ralco Model R302, K946320 3. Indications for Use (intended use): Model R72 is intended to be used as an X-Ray beam limitation device on portable and mo… | 1995 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 KPW devicesKPW Device, Beam Limiting, X-Ray, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 R72 is intended to be used as an X-Ray beam limitation device on portable and mobile diagnostic X-Ray units.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030487 · printed Nov 3, 2026
Cite this page
510(k) Report. “K030487: R 72.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K030487
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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