510(k) · Cleared
ClearedApollo Quattro (APQ-10M)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Weero Co., Ltd. · IPF Stimulator, Muscle, Powered
Cleared on Jun 8, 2026 as substantially equivalent to K241433 (Weero Co., Ltd., 2025) and 1 other predicate after a 206-day review. Its family tree reaches back 26 generations to 1995.
- Decided
- Jun 8, 2026
- Review
- 206 days
- Class
- Class II
- Product code
- IPF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 26 generations to K943450 (1995). 325 ancestors in all, the oldest K800617 (1980). No later device cites it as a predicate yet.
- Root · 26 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 22 generations between
- 3 generations backK201285 InMode Evolve System with the Tone ApplicatorInMode, Ltd. · 2021
- 2 generations backK210877 Evolve System with the T3 ApplicatorInMode, Ltd. · 2021
- 1 generation backK241433 EVE Synergy (EVE-20M)Weero Co., Ltd. · 2025
- This deviceK253542 Apollo Quattro (APQ-10M)Weero Co., Ltd. · 2026
Show all 26 generations
- Root · 26 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 25 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 24 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 23 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 22 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 21 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 20 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 19 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 18 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 17 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 16 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 15 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 14 generations backK051214 Aluma Skin Renewal SystemLumenis, Inc. · 2005
- 13 generations backK060448 Lumenis One Family of Systems; Lumenis One.Lumenis, Ltd. · 2006
- 12 generations backK072564 Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd. · 2008
- 11 generations backK082876 Beamax/ Formax Pulsed Light Device FamilySharplight Technologies, Ltd. · 2008
- 10 generations backK111303 Dermatological Treatment Device FamilySharplight Technologies, Ltd. · 2011
- 9 generations backK133837 Viora V-TotalViora, Ltd. · 2014
- 8 generations backK142093 V20 SystemViora, Ltd. · 2014
- 7 generations backK150035 V10 systemViora, Ltd. · 2015
- 6 generations backK153568 InMode Plus SystemInmode MD, Ltd. · 2016
- 5 generations backK172302 InMode PLUS SystemInmode MD, Ltd. · 2017
- 4 generations backK183450 EmBody SystemInmode MD, Ltd. · 2019
- 3 generations backK201285 InMode Evolve System with the Tone ApplicatorInMode, Ltd. · 2021
- 2 generations backK210877 Evolve System with the T3 ApplicatorInMode, Ltd. · 2021
- 1 generation backK241433 EVE Synergy (EVE-20M)Weero Co., Ltd. · 2025
- This deviceK253542 Apollo Quattro (APQ-10M)Weero Co., Ltd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −26 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −25 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −24 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −23 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −22 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −21 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −20 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −19 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −18 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −17 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −16 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −15 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| −14 | K051214 | Aluma Skin Renewal System | Lumenis, Inc. | 2005 | — |
| −13 | K060448 | Lumenis One Family of Systems; Lumenis One. | Lumenis, Ltd. | 2006 | — |
| −12 | K072564 | Alma Lasers Harmony XL Multi-Application Platform | Alma Lasers, Ltd. | 2008 | — |
| −11 | K082876 | Beamax/ Formax Pulsed Light Device Family | Sharplight Technologies, Ltd. | 2008 | — |
| −10 | K111303 | Dermatological Treatment Device Family | Sharplight Technologies, Ltd. | 2011 | — |
| −9 | K133837 | Viora V-Total | Viora, Ltd. | 2014 | — |
| −8 | K142093 | V20 System | Viora, Ltd. | 2014 | — |
| −7 | K150035 | V10 system | Viora, Ltd. | 2015 | — |
| −6 | K153568 | InMode Plus System | Inmode MD, Ltd. | 2016 | — |
| −5 | K172302 | InMode PLUS System | Inmode MD, Ltd. | 2017 | — |
| −4 | K183450 | EmBody System | Inmode MD, Ltd. | 2019 | — |
| −3 | K201285 | InMode Evolve System with the Tone Applicator | InMode, Ltd. | 2021 | — |
| −2 | K210877 | Evolve System with the T3 Applicator | InMode, Ltd. | 2021 | — |
| −1 | K241433 | EVE Synergy (EVE-20M) | Weero Co., Ltd. | 2025 | — |
| 0 (this device) | K253542 | Apollo Quattro (APQ-10M) | Weero Co., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1982 | 1 | 0 |
| 1984 | 1 | 0 |
| 1985 | 2 | 0 |
| 1986 | 3 | 0 |
| 1988 | 1 | 0 |
| 1989 | 3 | 0 |
| 1990 | 3 | 0 |
| 1991 | 10 | 0 |
| 1992 | 4 | 0 |
| 1993 | 9 | 0 |
| 1994 | 15 | 0 |
| 1995 | 17 | 0 |
| 1996 | 20 | 0 |
| 1997 | 23 | 0 |
| 1998 | 21 | 0 |
| 1999 | 12 | 0 |
| 2000 | 25 | 0 |
| 2001 | 27 | 0 |
| 2002 | 32 | 0 |
| 2003 | 23 | 0 |
| 2004 | 16 | 0 |
| 2005 | 10 | 0 |
| 2006 | 3 | 0 |
| 2007 | 4 | 0 |
| 2008 | 1 | 0 |
| 2009 | 4 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2019 | 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 IPF? 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 IPF device
- #1 K241433 EVE Synergy (EVE-20M)score 19.7 · 25 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 |
|---|---|---|---|
| * | K241433 | EVE Synergy (EVE-20M)Summary page 5…Device 510(k) No. Primary Predicate Device WEERO Co.,Ltd. EVE Synergy K241433 Secondary Predicate InMode Ltd. EVOLVE System with the T3 Applicator K210877 4. Description… | 2025 |
| * | K210877 | Evolve System with the T3 ApplicatorSummary page 5…d. EVE Synergy K241433 Secondary Predicate InMode Ltd. EVOLVE System with the T3 Applicator K210877 4. Description of the Device Apollo Quattro is a combination stimulator to deliver electrical muscle stimulation (EMS)… | 2021 |
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 31 years and passes through 11 companies; a new generation was cleared every 1.0 years on median.
- 11 of the 325 ancestors have a recall of any class.
How does its category compare?
All IPF devicesIPF Stimulator, Muscle, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · IPF
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IPF
257in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IPF
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IPF
8in 2025
MAUDE reports naming product code IPF, 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 | 8 | 143 | 0 | 11 |
| 2008 | 6 | 140 | 1 | 213 |
| 2009 | 7 | 216 | 0 | 150 |
| 2010 | 4 | 121 | 0 | 14 |
| 2011 | 4 | 275 | 1 | 25 |
| 2012 | 4 | 269 | 3 | 16 |
| 2013 | 10 | 180 | 0 | 6 |
| 2014 | 4 | 264 | 0 | 19 |
| 2015 | 3 | 43 | 0 | 11 |
| 2016 | 7 | 113 | 0 | 8 |
| 2017 | 5 | 110 | 0 | 2 |
| 2018 | 5 | 73 | 0 | 3 |
| 2019 | 4 | 133 | 0 | 10 |
| 2020 | 9 | 121 | 0 | 13 |
| 2021 | 15 | 98 | 0 | 3 |
| 2022 | 7 | 108 | 0 | 4 |
| 2023 | 9 | 255 | 1 | 8 |
| 2024 | 7 | 201 | 0 | 5 |
| 2025 | 3 | 257 | 0 | 8 |
| 2026 | 3 | 206 | 0 | — |
What is it indicated for?
Q-LF handpiece, Q-FX handpiece, Q-SC handpiece, and Q-BT handpiece in EMS mode are intended for:
• Relaxation of muscle spasms
• Prevention or retardation of disuse atrophy
• Increasing local blood circulation
• Muscle re-education
• Maintaining or increasing range of motion
• Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis
Q-EP handpiece in TENS mode is intended for:
• Symptomatic relief and management of chronic, intractable pain
• Post-surgical acute pain
• Post-trauma acute pain
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253542 · printed Nov 5, 2026
Cite this page
510(k) Report. “K253542: Apollo Quattro (APQ-10M).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K253542
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026