510(k) · Cleared
Cleared2 BASIC
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Capintec, Inc. · IYE Accelerator, Linear, Medical
Cleared on Apr 17, 2003 as substantially equivalent to K912249 (Theta Systems, Inc., 1991) and 2 other predicates after a 90-day review. Its family tree reaches back 2 generations to 1991.
- Decided
- Apr 17, 2003
- Review
- 90 days
- Class
- Class II
- Product code
- IYE
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K912250 (1991). 3 ancestors in all, the oldest K912249 (1991). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K912250 | Isorad (TM) Integral Buildup Photon Diodes | Theta Systems, Inc. | 1991 | — |
| −1 | K980826 | Equidose Solid State Diode Detectors | Cii Mastek, Inc. | 1998 | — |
| 0 (this device) | K030175 | 2 BASIC | Capintec, Inc. | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 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? (3)
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 |
|---|---|---|---|
| * | K912249 | Patient Dose MonitorSummary page 2…recognized PC to be used with application software. Predicate Device: Predicate Devices submitted by Theta Systems, Inc. Model PDM/2 Patient Dose Monitor 510(k) Number K912249 and lsorad Integral Buildup Photon Diodes 510(k) Number K912250. The 2 Basic uses the Equidose Diode Detector Design submitted by… | 1991 |
| * | K912250 | Isorad (TM) Integral Buildup Photon DiodesSummary page 2…Device: Predicate Devices submitted by Theta Systems, Inc. Model PDM/2 Patient Dose Monitor 510(k) Number K912249 and lsorad Integral Buildup Photon Diodes 510(k) Number K912250. The 2 Basic uses the Equidose Diode Detector Design submitted by MasTek DEM, Inc. 510(k) Number K980826 The 2 Basic meets the f… | 1991 |
| * | K980826 | Equidose Solid State Diode DetectorsSummary page 2…K912249 and lsorad Integral Buildup Photon Diodes 510(k) Number K912250. The 2 Basic uses the Equidose Diode Detector Design submitted by MasTek DEM, Inc. 510(k) Number K980826 The 2 Basic meets the following Safety Standards Medical Electrical Equipment, Part 1 General Requirements - UL2601-1:2nd Medica… | 1998 |
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 12 years and passes through 3 companies; a new generation was cleared every 6.6 years on median.
- None of the 3 ancestors has a recall.
- 1 other device also cites its predicate K912249.
How does its category compare?
All IYE devicesIYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 2 Basic is a solid state diode detector system coupled with a precision electrometer and PC for radiation measurement, data storage and display. It is intended to be used by trained medical physicists for the measurement of radiation output from radiation therapy treatment machines. The 2 Basic can be used with direct patient contact for entrance skin measurements, or in air, water, or other suitable phantoms materials for beam output measurements.
Measurement data is used to verify and document the beam characteristics of radiation therapy treatment machines for quality assurance programs and to very therapeutic doses delivered to patients during treatments.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030175 · printed Nov 5, 2026
Cite this page
510(k) Report. “K030175: 2 BASIC.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K030175
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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