510(k) · Cleared
Recalled · Class II · 2021Atomlab 400 and Atomlab 500 Dose Calibrators, Models 086-330, -331, -332, -335 and -336
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biodex Medical Systems, Inc. · KPT Calibrator, Dose, Radionuclide
Cleared on Feb 19, 2009 as substantially equivalent to K884312 (Atomic Products Corp., 1989) and 1 other predicate after a 13-day review. Its family tree reaches back 1 generation to 1989. It has been recalled 2 times.
- Decided
- Feb 19, 2009
- Review
- 13 days
- Class
- Class II
- Product code
- KPT
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 1 generation to K884312 (1989). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK884312 Atomlab 100, Model 086-250 & 200 Model 086-270Atomic Products Corp. · 1989
- This deviceK090296 Atomlab 400 and Atomlab 500 Dose Calibrators, Models 086-330, -331…Biodex Medical Systems, Inc. · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K884312 | Atomlab 100, Model 086-250 & 200 Model 086-270 | Atomic Products Corp. | 1989 | — |
| 0 (this device) | K090296 | Atomlab 400 and Atomlab 500 Dose Calibrators, Models 086-330, -331, -332, -335… | Biodex Medical Systems, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 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 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K884312 | Atomlab 100, Model 086-250 & 200 Model 086-270Summary page 1…ces. Classification #: 90 KPT, 21 CFR #892.1360 The Atonilab dose calibrators comply with Performance Standard IEC 1303 and IEC 61145. Predicate Devices: Atomlab 1.00 (K884312/A), Atomlab 200 (K884312/A), Capintec 25 (K071396). The basic detection, measurement process, design concepts, functionality, ca… | 1989 |
| * | K071396 | CRC 25 Series (CRC 25R, CRC 25PET, CRC 25W) Dose CalibratorsSummary page 1…he Atonilab dose calibrators comply with Performance Standard IEC 1303 and IEC 61145. Predicate Devices: Atomlab 1.00 (K884312/A), Atomlab 200 (K884312/A), Capintec 25 (K071396). The basic detection, measurement process, design concepts, functionality, calculations and algorithms remain the same as the p… | 2007 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 16, 2021 | Class II | Z-2580-2021 | Software design | When deleting a previously entered custom isotope, the software deletes the isotope, but not the associated dial setting. Possible other stored custom isotopes may then have incorrect dial settings and may lead to an incorrect dose… |
| Aug 16, 2021 | Class II | Z-2581-2021 | Software design | When deleting a previously entered custom isotope, the software deletes the isotope, but not the associated dial setting. Possible other stored custom isotopes may then have incorrect dial settings and may lead to an incorrect dose… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- 1 of the 2 ancestors has a recall of any class.
How does its category compare?
All KPT devicesKPT Calibrator, Dose, Radionuclide: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
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 Atomlab dose calibrators are used in Nuclear Medicine Departments, clinics and nuclear pharmacies for calibrating radioactive doses for administration to patients.
The instrument is used to verify the radioactivity of a radionuclide before administration to the patient.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090296 · printed Nov 3, 2026
Cite this page
510(k) Report. “K090296: Atomlab 400 and Atomlab 500 Dose Calibrators, Models 086-330, -331, -332, -335 and -336.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K090296
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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