510(k) · Cleared
ClearedApollo Duet (Model : APD-4000)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Weero Co. · PBX Massager, Vacuum, Radio Frequency Induced Heat
Cleared on Aug 25, 2022 as substantially equivalent to K210492 (Inmode MD, Ltd., 2021) after a 402-day review. Its family tree reaches back 4 generations to 2017. 1 later device descends from it.
- Decided
- Aug 25, 2022
- Review
- 402 days
- Class
- Class II
- Product code
- PBX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K171593 (2017). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK171593 InMode RF SystemInmode MD, Ltd. · 2017
- 3 generations backK182325 InMode RF SystemInmode MD, Ltd. · 2018
- 2 generations backK201150 InMode RF Multi-SystemInMode, Ltd. · 2020
- 1 generation backK210492 InMode RF Pro SystemInmode MD, Ltd. · 2021
- This deviceK212253 Apollo Duet (Model : APD-4000)Weero Co. · 2022
- Descendant · cites it directly · 0 of its ownK253261 Apollo Quattro (APQ-10M)Weero Co., Ltd. · 2026
Most influential descendants
Showing 1 of 1 · See all- K253261Apollo Quattro (APQ-10M)Weero Co., Ltd. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K171593 | InMode RF System | Inmode MD, Ltd. | 2017 | — |
| −3 | K182325 | InMode RF System | Inmode MD, Ltd. | 2018 | — |
| −2 | K201150 | InMode RF Multi-System | InMode, Ltd. | 2020 | — |
| −1 | K210492 | InMode RF Pro System | Inmode MD, Ltd. | 2021 | — |
| 0 (this device) | K212253 | Apollo Duet (Model : APD-4000) | Weero Co. | 2022 | — |
| +1 | K253261 | Apollo Quattro (APQ-10M) | Weero Co., Ltd. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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 PBX? 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 PBX device
- #1 K210877 Evolve System with the T3 Applicatorscore 23.6 · 24 generations · 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 |
|---|---|---|---|
| * | K210492 | InMode RF Pro SystemSummary page 4…keted Device) Manufacturer: InMode Ltd. Device Name: InMode RF Pro System 510(k) Number: K210492 Classification: Electrosurgical, Cutting & Coagulation & Accessories… | 2021 |
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 |
|---|---|---|---|
| K253261 | Apollo Quattro (APQ-10M) | 2026 | 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 1.1 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K253261 (Weero Co., Ltd., 2026) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K210492.
How does its category compare?
All PBX devicesPBX Massager, Vacuum, Radio Frequency Induced Heat: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · PBX
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PBX
200in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PBX
1in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PBX
4in 2025
MAUDE reports naming product code PBX, 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 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 12 |
| 2014 | 2 | — | 0 | 4 |
| 2015 | 5 | 181 | 0 | 0 |
| 2016 | 7 | 130 | 0 | 2 |
| 2017 | 6 | 132 | 1 | 1 |
| 2018 | 3 | 89 | 0 | 1 |
| 2019 | 8 | 147 | 0 | 4 |
| 2020 | 8 | 134 | 0 | 4 |
| 2021 | 6 | 169 | 0 | 8 |
| 2022 | 7 | 308 | 0 | 7 |
| 2023 | 9 | 227 | 0 | 7 |
| 2024 | 6 | 130 | 0 | 2 |
| 2025 | 7 | 200 | 0 | 4 |
| 2026 | 6 | 225 | 0 | — |
What is it indicated for?
Apollo duet(RF Mode) is intended for relief of minor muscle aches and pain, relief of muscle spasm, and temporary improvement of local blood circulation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K212253 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212253: Apollo Duet (Model : APD-4000).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K212253
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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