510(k) · Cleared
ClearedCDM
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio-Rad · LDM Instrumentation, High Pressure Liquid Chromatography
Cleared on Jul 8, 1996 as substantially equivalent to K833113 (Hewlett-Packard Co., 1983) after a 161-day review. Its family tree reaches back 1 generation to 1983.
- Decided
- Jul 8, 1996
- Review
- 161 days
- Class
- Class I
- Product code
- LDM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K833113 (1983). No later device cites it as a predicate yet.
- Root · 1 generation backK833113 Reporting Integrator 3392AHewlett-Packard Co. · 1983 · Recalled
- This deviceK960392 CDMBio-Rad · 1996
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K833113 | Reporting Integrator 3392A | Hewlett-Packard Co. | 1983 | 2 |
| 0 (this device) | K960392 | CDM | Bio-Rad | 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 LDM? 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 |
|---|---|---|---|
| * | K833113 | Reporting Integrator 3392ASummary page 1…Clinical use, 75 JQP To establish substantial equivalence to an existing predicate device, the CDM has been compared to the Hewlett-Packard 3392A Reporting Integrator (K833113). A review of the intended use of each system shows them to be essentially the same. The intended use of the CDM is stated as: A… | 1983 |
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 a recall.
How does its category compare?
All LDM devicesLDM Instrumentation, High Pressure Liquid Chromatography: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LDM
FDA has decided no LDM device since 2007.
Median 510(k) review, days · LDM
Too few LDM 510(k)s in any year since 2007 to give a median.
Recalls per year · LDM
No recall names LDM since 2007.
Adverse event reports per year · LDM
1in 2022
MAUDE reports naming product code LDM, 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 | 1 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 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 | 1 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
A software package and instrument interface that is used for quantitative analyses of high performance liquid chromatography (HPLC) test kits.
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/K960392 · printed Nov 6, 2026
Cite this page
510(k) Report. “K960392: CDM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K960392
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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