510(k) · Cleared
ClearedSynexis Sphere Rx
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synexis, LLC · FRA Purifier, Air, Ultraviolet, Medical
Cleared on Jun 14, 2023 as substantially equivalent to K211194 (Molekule, Inc., 2021) and 1 other predicate after a 383-day review. Its family tree reaches back 7 generations to 2003.
- Decided
- Jun 14, 2023
- Review
- 383 days
- Class
- Class II
- Product code
- FRA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K023830 (2003). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK023830 Airocide TI02Kes Science & Technology, Inc. · 2003
- 6 generations backK033448 Electro-Optical Air Sterilizer with IonizerJohn Mfg., Ltd. · 2004
- 5 generations backK052732 Abracair Air Cleaner, Model QTZ300-60; Abracair Air Cleaner, Model…Abracair, Inc. · 2006
- 4 generations backK161468 Transformair Indoor Air PurifierTransformair, LLC · 2017
- 3 generations backK200500 Molekule Air Pro RXMolekule, Inc. · 2020
- 2 generations backK202339 Molekule Air Mini, Molekule Air Mini +Molekule, Inc. · 2021
- 1 generation backK211194 Molekule Air ProMolekule, Inc. · 2021
- This deviceK221540 Synexis Sphere RxSynexis, LLC · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K023830 | Airocide TI02 | Kes Science & Technology, Inc. | 2003 | — |
| −6 | K033448 | Electro-Optical Air Sterilizer with Ionizer | John Mfg., Ltd. | 2004 | — |
| −5 | K052732 | Abracair Air Cleaner, Model QTZ300-60; Abracair Air Cleaner, Model TI 100-30P | Abracair, Inc. | 2006 | — |
| −4 | K161468 | Transformair Indoor Air Purifier | Transformair, LLC | 2017 | — |
| −3 | K200500 | Molekule Air Pro RX | Molekule, Inc. | 2020 | — |
| −2 | K202339 | Molekule Air Mini, Molekule Air Mini + | Molekule, Inc. | 2021 | — |
| −1 | K211194 | Molekule Air Pro | Molekule, Inc. | 2021 | — |
| 0 (this device) | K221540 | Synexis Sphere Rx | Synexis, LLC | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 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 FRA? 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 FRA device
- #1 K212644 Aura Stormscore 13.9 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K211194 | Molekule Air ProSummary page 4…Class II (21 CFR 880.6500) Classification Name Medical UV Air Purifier Predicate Devices: Primary K211194 – Molekule Air Pro Additional K201220 – Aerus Medical Guard… | 2021 |
| * | K201220 | Aerus Medical Guardian,model F170ASummary page 4…s: Primary K211194 – Molekule Air Pro Additional K201220 – Aerus Medical Guardian Device Description The Synexis Sphere Rx is a photocatalytic air purifier that utilizes… | 2020 |
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 20 years and passes through 6 companies; a new generation was cleared every 1.6 years on median.
- None of the 8 ancestors has a recall.
- 1 other device also cites its predicate K211194.
How does its category compare?
All FRA devicesFRA Purifier, Air, Ultraviolet, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · FRA
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FRA
205in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FRA
No recall names FRA since 2007.
Adverse event reports per year · FRA
2in 2024
MAUDE reports naming product code FRA, 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 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 5 | 190 | 0 | 1 |
| 2022 | 4 | 175 | 0 | 1 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 4 | 205 | 0 | 2 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Synexis Sphere Rx is a stand-alone air purifier device intended for medical purposes and is used for the reduction of bacteria and viruses in the air. The device is intended for use in professional healthcare environments. The Sphere Rx is not intended for use near HF surgical equipment or MRI settings. The Synexis Sphere Rx air purifier demonstrated a ≥ 4 log reduction of bacteria and viruses under the following exposure/working conditions: Organism…
Read the full statement (173 words)
The Synexis Sphere Rx is a stand-alone air purifier device intended for medical purposes and is used for the reduction of bacteria and viruses in the air. The device is intended for use in professional healthcare environments. The Sphere Rx is not intended for use near HF surgical equipment or MRI settings.
The Synexis Sphere Rx air purifier demonstrated a ≥ 4 log reduction of bacteria and viruses under the following exposure/working conditions:
Organism Type Organism Name Test Temp/RH Avg Net Log Reduction/Time@ High Fan Speed
Gram- bacteria K. aerogenes 25±3 deg C, 60 ±5% RH 4.25 / 240m
Gram+ bacteria S. epidermidis 25±3 deg C, 60 ±5% RH 4.19 / 360m
Virus MS2 25±3 deg C, 60 ±5% RH 4.55 / 300m
Organism Type Organism Name Test Temp/RH Avg Net Log Reduction/Time@ Low Fan Speed
Gram- bacteria K. aerogenes 25±3 deg C, 60 ±5% RH 4.25 / 240m
Gram+ bacteria S. epidermidis 25±3 deg C, 60 ±5% RH 4.13 / 480m
Virus MS2 25±3 deg C, 60 ±5% RH 4.11 / 480m
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221540 · printed Nov 4, 2026
Cite this page
510(k) Report. “K221540: Synexis Sphere Rx.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K221540
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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