510(k) · Cleared
ClearedHelios+ UV-C System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Preventamed Technologies, Inc. Dba Surfacide Manufacturing · QXJ Whole Room Microbial Reduction Device
Cleared on May 27, 2025 as substantially equivalent to DEN230007 (Xenex Disinfection Services, Inc., 2023) after a 270-day review. Its family tree reaches back 1 generation to 2023.
- Decided
- May 27, 2025
- Review
- 270 days
- Class
- Class II
- Product code
- QXJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN230007 (2023). No later device cites it as a predicate yet.
- Root · 1 generation backDEN230007 LightStrike+ (MXSUV1-SL and MXSUV1-FT)Xenex Disinfection Services, Inc. · 2023
- This deviceK242604 Helios+ UV-C SystemPreventamed Technologies, Inc. Dba Surfacide Manufacturing · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN230007 | LightStrike+ (MXSUV1-SL and MXSUV1-FT) | Xenex Disinfection Services, Inc. | 2023 | — |
| 0 (this device) | K242604 | Helios+ UV-C System | Preventamed Technologies, Inc. Dba Surfacide Manufacturing | 2025 | — |
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 QXJ? 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 |
|---|---|---|---|
| * | DEN230007 | LightStrike+ (MXSUV1-SL and MXSUV1-FT)Summary page 5…e Device 21 CFR 807.92(a)(3) Predicate # DEN230007 Predicate Trade Name LightStrikeTM+ Product Code QXJ DEN230007… | 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?
- Its one ancestor has no recall.
How does its category compare?
All QXJ devicesQXJ Whole Room Microbial Reduction Device: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · QXJ
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QXJ
Too few QXJ 510(k)s in any year since 2007 to give a median.
Recalls per year · QXJ
No recall names QXJ since 2007.
Adverse event reports per year · QXJ
1in 2025
MAUDE reports naming product code QXJ, 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 | 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 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Helios+ is a 253.7nm wavelength, high intensity, germicidal UV-C light system intended to perform microbial reduction on non-porous, non-critical medical device surfaces, free from visual soiling, after manual cleaning and disinfection practices. Helios+ is intended for use in unoccupied operating rooms, hospital rooms and other clinical settings where non-critical medical devices are present as an adjunct to existing manual cleaning and disinfection practices. The system is for over-the-counter (OTC) use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K242604 · printed Nov 6, 2026
Cite this page
510(k) Report. “K242604: Helios+ UV-C System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K242604
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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