510(k) · Cleared
ClearedStandard Imaging Ivb 1000 Well Chamber
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Standard Imaging, Inc. · KPT Calibrator, Dose, Radionuclide
Cleared on Nov 9, 2001 after a 16-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below).
- Decided
- Nov 9, 2001
- Review
- 16 days
- Class
- Class II
- Product code
- KPT
- Recalls
- None
- Predicates
- 1
The summary cites one number, which could not be confirmed as its predicate (see the table below).
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 KPT? 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K0001825 | Standard Imaging HDR 1000 Plus/IVB 1000 Well Chambers Number could not be read |
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.
How does its category compare?
All KPT devicesKPT Calibrator, Dose, Radionuclide: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KPT
1in 2019
2026 to Oct 25, outlined.
Median 510(k) review, days · KPT
Too few KPT 510(k)s in any year since 2007 to give a median.
Recalls per year · KPT
1in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KPT
No MAUDE report names KPT since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 1 | — | 1 | 0 |
| 2011 | 0 | — | 1 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 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?
The Standard Imaging IVB 1000 Well Chamber is a well-type chamber. It is specifically designed to measure the amount of radiation of high-dose-rate (HDR), low-dose-rate (LDR) and intravascular (IVB) brachytherapy (gamma and beta) sources, with the appropriate calibration from an accredited dosimetry calibration laboratory. Sources must be measured using the appropriate and specific source holder as described in the IVB 1000 labeling. To check the bremstralung component of a source, the X-Ray Contamination Test Tool, an accessory to the IVB 1000, should be used.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K013548 · printed Nov 5, 2026
Cite this page
510(k) Report. “K013548: Standard Imaging Ivb 1000 Well Chamber.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K013548
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Page last updated Nov 3, 2026