510(k) · Cleared
ClearedPuma Model Version 1.0
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Prowess, Inc. · IYE Accelerator, Linear, Medical
Cleared on Jun 18, 2010 as substantially equivalent to K972275 (Siemens Medical Solutions USA, Inc., 1997) after an 88-day review. Its family tree reaches back 2 generations to 1991. 2 later devices descend from it.
- Decided
- Jun 18, 2010
- Review
- 88 days
- Class
- Class II
- Product code
- IYE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K913612 (1991). 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK913612 SequencerImpac Medical Systems, Inc. · 1991
- 1 generation backK972275 Lantis TreatstationSiemens Medical Solutions USA, Inc. · 1997 · Recalled
- This deviceK100801 Puma Model Version 1.0Prowess, Inc. · 2010
- Descendant · cites it directly · 1 of its ownK122616 Panther Ois/R & V Model Version 2.0Prowess, Inc. · 2012
- Descendant · 2 generations on · 0 of its ownK211760 Panther OISProwess, Inc. · 2021
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 |
|---|---|---|---|---|---|
| −2 | K913612 | Sequencer | Impac Medical Systems, Inc. | 1991 | — |
| −1 | K972275 | Lantis Treatstation | Siemens Medical Solutions USA, Inc. | 1997 | 5 |
| 0 (this device) | K100801 | Puma Model Version 1.0 | Prowess, Inc. | 2010 | — |
| +1 | K122616 | Panther Ois/R & V Model Version 2.0 | Prowess, Inc. | 2012 | — |
| +2 | K211760 | Panther OIS | Prowess, Inc. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2021 | 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 IYE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new IYE device
- #1 K252977 Halcyon, Ethos Radiotherapy System (5.0)score 18.8 · 18 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K972275 | Lantis TreatstationSummary page 1…erify System Oncology Information System 3. Predicate Devices: a) Siemens Medical System's Lantis Treatstation - K972275 b) Varian Medical System's 4D Integrated Treatment Console (4DITC) - K91132 4. Device Description Puma is a medi… | 1997 |
| Kept off the family tree | K091132 | FDA’s K091132 is 4D Integrated Treatment Console Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2009 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K122616 | Panther Ois/R & V Model Version 2.0 | 2012 | 1 |
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 19 years and passes through 3 companies; a new generation was cleared every 12.8 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K122616 (Prowess, Inc., 2012) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K972275.
How does its category compare?
All IYE devicesIYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · IYE
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYE
170in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYE
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IYE
101in 2025
MAUDE reports naming product code IYE, 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 | 23 | 44 | 78 | 155 |
| 2008 | 14 | 69 | 49 | 114 |
| 2009 | 20 | 63 | 22 | 174 |
| 2010 | 23 | 74 | 27 | 246 |
| 2011 | 11 | 94 | 73 | 280 |
| 2012 | 28 | 106 | 20 | 128 |
| 2013 | 18 | 88 | 11 | 96 |
| 2014 | 20 | 100 | 14 | 124 |
| 2015 | 20 | 108 | 8 | 100 |
| 2016 | 21 | 97 | 7 | 97 |
| 2017 | 23 | 94 | 7 | 125 |
| 2018 | 21 | 58 | 7 | 85 |
| 2019 | 19 | 83 | 2 | 91 |
| 2020 | 20 | 67 | 4 | 74 |
| 2021 | 19 | 86 | 5 | 68 |
| 2022 | 12 | 172 | 3 | 66 |
| 2023 | 18 | 129 | 7 | 128 |
| 2024 | 9 | 239 | 1 | 81 |
| 2025 | 12 | 170 | 1 | 101 |
| 2026 | 14 | 120 | 4 | — |
What is it indicated for?
The intended use of Puma is to allow the radiation therapist to deliver treatment to the patient via linear accelerator (linac). This entails selection of the patient, selection of the day's correct treatment for the patient, Set tip, and delivery of the treatment fields and recording of the treatment. Puma supports auto-sequencing, a process of automatically downloading a group of fields or segments from the record and verify systemn to the control of…
Read the full statement (116 words)
The intended use of Puma is to allow the radiation therapist to deliver treatment to the patient via linear accelerator (linac). This entails selection of the patient, selection of the day's correct treatment for the patient, Set tip, and delivery of the treatment fields and recording of the treatment. Puma supports auto-sequencing, a process of automatically downloading a group of fields or segments from the record and verify systemn to the control of the linear accelerator sequentially, without user intervention. In addition, Puma also supports IMRT (Intensity Modulated Radiation Therapy), a process of shaping, modifying and moving the beam around a target to maximize the dose at the target and minimize the dose to normal structures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100801 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100801: Puma Model Version 1.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100801
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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