510(k) · Cleared
ClearedR 302
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 May 11, 1995 after a 134-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 9 later devices descend from it.
- Decided
- May 11, 1995
- Review
- 134 days
- Class
- Class II
- Product code
- KPW
- Recalls
- None
- Predicates
- 0
9 later devices descend from it, 2 citing it directly.
- This deviceK946320 R 302Ralco S.R.L. · 1995
- Descendant · cites it directly · 5 of its ownK080742 Verisuite 1.6, Verisuite-Particle 1.6Medcom GmbH · 2008
- Descendant · 2 generations on · 3 of its ownK092653 Verisuite and Verisuite-Particle, Version 1.8Medcom GmbH · 2009
- Descendant · 3 generations on · 2 of its ownK133914 Verisuite 1.8, Verisuite-Particle 1.8, Verisuite, Verisuite-ParticleMedcom GmbH · 2014
- Descendant · cites it directly · 2 of its ownK030487 R 72Ralco S.R.L. · 2003
- Descendant · 3 generations on · 0 of its ownK181789 VeriSuiteMedcom GmbH · 2018
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K080742Verisuite 1.6, Verisuite-Particle 1.6Medcom GmbH · 2008 · cites it directly5descendants
- K092653Verisuite and Verisuite-Particle, Version 1.8Medcom GmbH · 2009 · 2 generations on3descendants
- K133914Verisuite 1.8, Verisuite-Particle 1.8, Verisuite, Verisuite-ParticleMedcom GmbH · 2014 · 3 generations on2descendants
- K030487R 72Ralco S.R.L. · 2003 · cites it directly2descendants
- K181789VeriSuiteMedcom GmbH · 2018 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K946320 | R 302 | Ralco S.R.L. | 1995 | — |
| +1 | K080742 | Verisuite 1.6, Verisuite-Particle 1.6 | Medcom GmbH | 2008 | — |
| +2 | K092653 | Verisuite and Verisuite-Particle, Version 1.8 | Medcom GmbH | 2009 | — |
| +3 | K133914 | Verisuite 1.8, Verisuite-Particle 1.8, Verisuite, Verisuite-Particle | Medcom GmbH | 2014 | — |
| +1 | K030487 | R 72 | Ralco S.R.L. | 2003 | — |
| +3 | K181789 | VeriSuite | Medcom GmbH | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (9)
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?
- Of its descendants, K080742 (Medcom GmbH, 2008) has gone furthest, with 5 descendants of its own.
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 | — |
https://510kreport.com/device/K946320 · printed Nov 6, 2026
Cite this page
510(k) Report. “K946320: R 302.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K946320
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026