510(k) · Cleared
ClearedPPH Saliva Collection Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Permantis Public Health · QBD Microbial Nucleic Acid Storage And Stabilization Device
Cleared on Oct 11, 2024 as substantially equivalent to K223497 (Spectrum Solutions, LLC, 2023) after a 203-day review. Its family tree reaches back 3 generations to 2018.
- Decided
- Oct 11, 2024
- Review
- 203 days
- Class
- Class II
- Product code
- QBD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to DEN170029 (2018). No later device cites it as a predicate yet.
- Root · 3 generations backDEN170029 PrimeStore MTMLonghorn Vaccines and Diagnostics, LLC · 2018
- 2 generations backK202641 DNA/RNA Shield Collection TubeZymo Research · 2020
- 1 generation backK223497 Spectrum Saliva Collection DeviceSpectrum Solutions, LLC · 2023
- This deviceK240797 PPH Saliva Collection KitPermantis Public Health · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | DEN170029 | PrimeStore MTM | Longhorn Vaccines and Diagnostics, LLC | 2018 | — |
| −2 | K202641 | DNA/RNA Shield Collection Tube | Zymo Research | 2020 | — |
| −1 | K223497 | Spectrum Saliva Collection Device | Spectrum Solutions, LLC | 2023 | — |
| 0 (this device) | K240797 | PPH Saliva Collection Kit | Permantis Public Health | 2024 | — |
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 QBD? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new QBD device
- #1 K202641 DNA/RNA Shield Collection Tubescore 18.5 · 1 generation · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K223497 | Spectrum Saliva Collection DeviceSummary page 7…und in the predicate device and other cleared saliva collection devices on the market. Feature Device K240797 Predicate: K223497 Device Trade Name PPH Saliva Collection Device Spectrum Solutions Saliva Collection… | 2023 |
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?
- The line of descent spans 6 years and passes through 4 companies; a new generation was cleared every 2.2 years on median.
- None of the 3 ancestors has a recall.
How does its category compare?
All QBD devicesQBD Microbial Nucleic Acid Storage And Stabilization Device: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · QBD
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QBD
651in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QBD
2in 2022
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · QBD
No MAUDE report names QBD 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 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 2 | — | 2 (2) | 0 |
| 2023 | 5 | 286 | 0 | 0 |
| 2024 | 5 | 651 | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The PPH Saliva Collection Kit is designed for use in the non-invasive collection, inactivation, and stabilization of viral nucleic acids for in vitro diagnostic testing of saliva samples. The device is intended to inactivate and stabilize human clinical saliva samples from the collection site to the laboratory at room temperature. The device is intended to be used by a health care provider for the collection of saliva samples suspected of containing SARS-CoV-2. The saliva sample is stabilized and suitable for use with legally marketed molecular diagnostic devices.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K240797 · printed Nov 6, 2026
Cite this page
510(k) Report. “K240797: PPH Saliva Collection Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K240797
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