510(k) · Cleared
ClearedNuEra Tight RF Model APMD145.M70-US
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bios S.R.L. · PBX Massager, Vacuum, Radio Frequency Induced Heat
Cleared on May 2, 2023 as substantially equivalent to K210867 (Bios S.R.L., 2021) after a 125-day review. Its family tree reaches back 5 generations to 2012.
- Decided
- May 2, 2023
- Review
- 125 days
- Class
- Class II
- Product code
- PBX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K122389 (2012). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK122389 TrusculptCutera, Inc. · 2012 · Recalled
- 4 generations backK132949 PellefirmEllman International, Inc. · 2014
- 3 generations backK151296 Family of Radiofrequency System (Biorevital RF MED, ThermiSmooth 250)Bios S.R.L. · 2015 · Recalled
- 2 generations backK200359 NuEra Tight, NuEra Tight EMSBios S.R.L. · 2020
- 1 generation backK210867 NuEra Tight RF, NuEra Tight RF PlusBios S.R.L. · 2021
- This deviceK223907 NuEra Tight RF Model APMD145.M70-USBios S.R.L. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K122389 | Trusculpt | Cutera, Inc. | 2012 | 1 |
| −4 | K132949 | Pellefirm | Ellman International, Inc. | 2014 | — |
| −3 | K151296 | Family of Radiofrequency System (Biorevital RF MED, ThermiSmooth 250) | Bios S.R.L. | 2015 | 1 |
| −2 | K200359 | NuEra Tight, NuEra Tight EMS | Bios S.R.L. | 2020 | — |
| −1 | K210867 | NuEra Tight RF, NuEra Tight RF Plus | Bios S.R.L. | 2021 | — |
| 0 (this device) | K223907 | NuEra Tight RF Model APMD145.M70-US | Bios S.R.L. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 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 |
|---|---|---|---|
| * | K210867 | NuEra Tight RF, NuEra Tight RF PlusSummary page 4…es Electrosurgical cutting and coagulation device and accessories Predicate and Reference Devices 510(k) Ref ‘Pro Code/Reg No | Trade Name Applicant Predicate Device K210867 PBX, 878.4400 APMD145.M70 US Bios s.r.l. Device Description NuEra Tight RF Family is a family of devices designed to develop lo… | 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 11 years and passes through 3 companies; a new generation was cleared every 1.7 years on median.
- 2 of the 6 ancestors have a recall of any class.
- 3 other devices also cite its predicate K210867.
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. 2023, 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?
The NuEra Tight RF Model APMD145.M70-US is intended for:
to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation.
to provide, with a massage device, a temporary reduction in the appearance of cellulite.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K223907 · printed Nov 4, 2026
Cite this page
510(k) Report. “K223907: NuEra Tight RF Model APMD145.M70-US.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K223907
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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