510(k) · Cleared
ClearedRemedi HS Drug Profiling System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio-Rad · DNI Liquid Chromatography, Amphetamine
Cleared on Mar 27, 1995 after a 360-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 later devices descend from it.
- Decided
- Mar 27, 1995
- Review
- 360 days
- Class
- Class II
- Product code
- DNI
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 1 citing it directly.
- This deviceK941596 Remedi HS Drug Profiling SystemBio-Rad · 1995
- Descendant · cites it directly · 5 of its ownK043341 Bioplex 2200 Ana Screen with Medical Decision Support Software for…Bio-Rad Laboratories, Inc. · 2005 · Recalled
- Descendant · 2 generations on · 3 of its ownK080896 Pathwork Diagnostics Tissue of Origin TestPathwork Diagnostics, Inc. · 2008
- Descendant · 3 generations on · 2 of its ownK092967 Pathwork Tissue of Origin Test Kit-Ffpe (Origin Test Kit-FfpePathwork Diagnostics · 2010
- Descendant · 4 generations on · 1 of its ownK120489 Tissue of Origin Test Kit FfpePathwork Diagnostics, Inc. · 2012
- Descendant · 5 generations on · 0 of its ownK173839 Tissue of Origin Test Kit-FFPECancer Genetics, Inc. · 2018
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K043341Bioplex 2200 Ana Screen with Medical Decision Support Software for Use with Bioplex 2200…Bio-Rad Laboratories, Inc. · 2005 · cites it directly5descendants
- K080896Pathwork Diagnostics Tissue of Origin TestPathwork Diagnostics, Inc. · 2008 · 2 generations on3descendants
- K092967Pathwork Tissue of Origin Test Kit-Ffpe (Origin Test Kit-FfpePathwork Diagnostics · 2010 · 3 generations on2descendants
- K120489Tissue of Origin Test Kit FfpePathwork Diagnostics, Inc. · 2012 · 4 generations on1descendant
- K173839Tissue of Origin Test Kit-FFPECancer Genetics, Inc. · 2018 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K941596 | Remedi HS Drug Profiling System | Bio-Rad | 1995 | — |
| +1 | K043341 | Bioplex 2200 Ana Screen with Medical Decision Support Software for Use with… | Bio-Rad Laboratories, Inc. | 2005 | 2 |
| +2 | K080896 | Pathwork Diagnostics Tissue of Origin Test | Pathwork Diagnostics, Inc. | 2008 | — |
| +3 | K092967 | Pathwork Tissue of Origin Test Kit-Ffpe (Origin Test Kit-Ffpe | Pathwork Diagnostics | 2010 | — |
| +4 | K120489 | Tissue of Origin Test Kit Ffpe | Pathwork Diagnostics, Inc. | 2012 | — |
| +5 | K173839 | Tissue of Origin Test Kit-FFPE | Cancer Genetics, Inc. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 2 | 0 |
| 2018 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DNI? 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K043341 | Bioplex 2200 Ana Screen with Medical Decision Support Software for Use with Bioplex 2200… | 2005 | 5 |
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?
- Of its descendants, K043341 (Bio-Rad Laboratories, Inc., 2005) has gone furthest, with 5 descendants of its own.
How does its category compare?
All DNI devicesDNI Liquid Chromatography, Amphetamine: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DNI
FDA has decided no DNI device since 2007.
Median 510(k) review, days · DNI
Too few DNI 510(k)s in any year since 2007 to give a median.
Recalls per year · DNI
No recall names DNI since 2007.
Adverse event reports per year · DNI
No MAUDE report names DNI since 2007.
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 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 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 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K941596 · printed Nov 6, 2026
Cite this page
510(k) Report. “K941596: Remedi HS Drug Profiling System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K941596
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026