510(k) · Cleared
ClearedPathodx Respiratory Virus Panel Model PKRP1
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diagnostic Products Corp. · LKT Respiratory Syncytial Virus, Antigen, Antibody, Ifa
Cleared on Mar 18, 1999 as substantially equivalent to K896635 (Baxter Healthcare Corp, 1990) and 1 other predicate after a 176-day review. Its family tree reaches back 1 generation to 1990.
- Decided
- Mar 18, 1999
- Review
- 176 days
- Class
- Class I
- Product code
- LKT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K896635 (1990). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK896635 Viral Respiratory Indirect Fluores. Mono. AntibodyBaxter Healthcare Corp · 1990
- This deviceK983336 Pathodx Respiratory Virus Panel Model PKRP1Diagnostic Products Corp. · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K896635 | Viral Respiratory Indirect Fluores. Mono. Antibody | Baxter Healthcare Corp | 1990 | — |
| 0 (this device) | K983336 | Pathodx Respiratory Virus Panel Model PKRP1 | Diagnostic Products Corp. | 1999 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 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 LKT? 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 |
|---|---|---|---|
| * | K896635 | Viral Respiratory Indirect Fluores. Mono. AntibodySummary page 1…ducts Corporation 5700 West 96" St Los Angeles, CA 90045 DPC’s Establishment Registration Number is 2017183 Bartels Viral Respiratory Screening and Identification Kit (K896635) | Light Diagnostic Respiratory Viral Screen Indirect Immunofluorescence Assay by Chemicon International, Inc. (K922801) Direct… | 1990 |
| * | K922801 | Resp. Panel 1 Indirect Immunofluorescence AssaySummary page 1…al Respiratory Screening and Identification Kit (K896635) | Light Diagnostic Respiratory Viral Screen Indirect Immunofluorescence Assay by Chemicon International, Inc. (K922801) Direct immunofluorescence test for the qualitative detection of seven common respiratory viruses. 1 @o1e 03/1… | 1993 |
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?
- None of the 2 ancestors has a recall.
How does its category compare?
All LKT devicesLKT Respiratory Syncytial Virus, Antigen, Antibody, Ifa: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LKT
1in 2008
2026 to Oct 25, outlined.
Median 510(k) review, days · LKT
Too few LKT 510(k)s in any year since 2007 to give a median.
Recalls per year · LKT
No recall names LKT since 2007.
Adverse event reports per year · LKT
No MAUDE report names LKT 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 | 1 | — | 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 | — |
What is it indicated for?
The PathoDx Respiratory Virus Panel (RVP) kit is a direct immunofluorescence test for the qualitative detection of 7 common respiratory viruses (respiratory syncytial virus, influenza A, influenza B, parainfluenza viruses 1,2, and 3, and adenovirus) in prepared direct patient specimens and following growth in cell culture. The materials supplied are intended for in vifro use only.
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/K983336 · printed Nov 6, 2026
Cite this page
510(k) Report. “K983336: Pathodx Respiratory Virus Panel Model PKRP1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K983336
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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