510(k) · Cleared
ClearedSpectrum Saliva Collection Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spectrum Solutions, LLC · QBD Microbial Nucleic Acid Storage And Stabilization Device
Cleared on Feb 17, 2023 as substantially equivalent to K202641 (Zymo Research, 2020) after an 88-day review. Its family tree reaches back 2 generations to 2018. 1 later device descends from it.
- Decided
- Feb 17, 2023
- Review
- 88 days
- Class
- Class II
- Product code
- QBD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN170029 (2018). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backDEN170029 PrimeStore MTMLonghorn Vaccines and Diagnostics, LLC · 2018
- 1 generation backK202641 DNA/RNA Shield Collection TubeZymo Research · 2020
- This deviceK223497 Spectrum Saliva Collection DeviceSpectrum Solutions, LLC · 2023
- Descendant · cites it directly · 0 of its ownK240797 PPH Saliva Collection KitPermantis Public Health · 2024
Most influential descendants
Showing 1 of 1 · See all- K240797PPH Saliva Collection KitPermantis Public Health · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | DEN170029 | PrimeStore MTM | Longhorn Vaccines and Diagnostics, LLC | 2018 | — |
| −1 | K202641 | DNA/RNA Shield Collection Tube | Zymo Research | 2020 | — |
| 0 (this device) | K223497 | Spectrum Saliva Collection Device | Spectrum Solutions, LLC | 2023 | — |
| +1 | K240797 | PPH Saliva Collection Kit | Permantis Public Health | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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 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 |
|---|---|---|---|
| * | K202641 | DNA/RNA Shield Collection TubeSummary page 4…II, 21 CFR 866.2950 Product Code: QBD Predicate Device: 510(k) Number Device Manufacturer K202641 DNA/RNA Shield Collection Tube ZYMO Research Device Description: The Spectrum Solutions S… | 2020 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K240797 | PPH Saliva Collection Kit | 2024 | 0 |
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 5 years and passes through 3 companies; a new generation was cleared every 2.7 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K240797 (Permantis Public Health, 2024) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K202641.
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. 2023, 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 Spectrum Solutions Saliva Collection Device 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 saliva sample is stabilized and suitable for use with legally marketed molecular diagnostic devices. The device is intended to be used by a health care provider for samples suspected of containing SARS-CoV-2.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223497 · printed Nov 4, 2026
Cite this page
510(k) Report. “K223497: Spectrum Saliva Collection Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K223497
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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