510(k) · Cleared
ClearedSequential Sample Multi-Photon Detector
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biotraces, Inc. · JJJ Counter (Beta, Gamma) For Clinical Use
Cleared on Aug 16, 1996 as substantially equivalent to K770088 (Beckman Instruments, Inc., 1977) after a 31-day review. Its family tree reaches back 1 generation to 1977.
- Decided
- Aug 16, 1996
- Review
- 31 days
- Class
- Class I
- Product code
- JJJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K770088 (1977). No later device cites it as a predicate yet.
- Root · 1 generation backK770088 Gamma 4000 Scintillation CounterBeckman Instruments, Inc. · 1977
- This deviceK962762 Sequential Sample Multi-Photon DetectorBiotraces, Inc. · 1996
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K770088 | Gamma 4000 Scintillation Counter | Beckman Instruments, Inc. | 1977 | — |
| 0 (this device) | K962762 | Sequential Sample Multi-Photon Detector | Biotraces, Inc. | 1996 | — |
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 JJJ? 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K770088 | Gamma 4000 Scintillation CounterSummary page 1…tially equivalent in specifications and principles of operation to the Gamma 5500 Counting System (originally listed as Gamma 4000 Scintillation Counter), 510(k) Number: K770088, manufactured by Beckman Instruments, Inc., Scientific Instruments Division, Irvine, California 92713. The SSMPD is a twelve sa… | 1977 |
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?
- Its one ancestor has no recall.
How does its category compare?
All JJJ devicesJJJ Counter (Beta, Gamma) For Clinical Use: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JJJ
FDA has decided no JJJ device since 2007.
Median 510(k) review, days · JJJ
Too few JJJ 510(k)s in any year since 2007 to give a median.
Recalls per year · JJJ
7in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JJJ
2in 2012
MAUDE reports naming product code JJJ, 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 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 2 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 7 | 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 | — |
What is it indicated for?
The SSMPD is intended as a general use clinical laboratory gamma radiation counter. The SSMPD is designed for use by operators qualified to measure gamma-ray emissions from radiolabelled reagents within particular energy bands or energy regions of interest (ROI) as part of diagnostic radioassay or radioimmunoassay methods. The standard quantitative units of measure reported are the measured count per minute (cpm) and the calculated disintegrations per minute (dpm).
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/K962762 · printed Nov 6, 2026
Cite this page
510(k) Report. “K962762: Sequential Sample Multi-Photon Detector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K962762
Report an extraction error
Are you the manufacturer?
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