510(k) · Cleared
ClearedPellefirm
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ellman International, Inc. · PBX Massager, Vacuum, Radio Frequency Induced Heat
Cleared on Feb 20, 2014 as substantially equivalent to K122389 (Cutera, Inc., 2012) after a 154-day review. Its family tree reaches back 1 generation to 2012. 48 later devices descend from it.
- Decided
- Feb 20, 2014
- Review
- 154 days
- Class
- Class II
- Product code
- PBX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K122389 (2012). 48 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK122389 TrusculptCutera, Inc. · 2012 · Recalled
- This deviceK132949 PellefirmEllman International, Inc. · 2014
- Descendant · cites it directly · 16 of its ownK171262 TempSureCynosure, Inc. · 2017
- Descendant · cites it directly · 16 of its ownK143040 Exilis XPBTL Industries, Inc. · 2015
- Descendant · 2 generations on · 15 of its ownK182365 TempSure SystemCynosure, Inc. · 2018
- Descendant · 2 generations on · 14 of its ownK190678 TempSureCynosure, Inc. · 2019
- Descendant · 3 generations on · 13 of its ownK200241 TempSure SystemCynosure, LLC · 2020
Showing 5 of 48 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 48 · See all- K171262TempSureCynosure, Inc. · 2017 · cites it directly16descendants
- K143040Exilis XPBTL Industries, Inc. · 2015 · cites it directly16descendants
- K182365TempSure SystemCynosure, Inc. · 2018 · 2 generations on15descendants
- K190678TempSureCynosure, Inc. · 2019 · 2 generations on14descendants
- K200241TempSure SystemCynosure, LLC · 2020 · 3 generations on13descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K122389 | Trusculpt | Cutera, Inc. | 2012 | 1 |
| 0 (this device) | K132949 | Pellefirm | Ellman International, Inc. | 2014 | — |
| +1 | K171262 | TempSure | Cynosure, Inc. | 2017 | — |
| +1 | K143040 | Exilis XP | BTL Industries, Inc. | 2015 | — |
| +2 | K182365 | TempSure System | Cynosure, Inc. | 2018 | — |
| +2 | K190678 | TempSure | Cynosure, Inc. | 2019 | — |
| +3 | K200241 | TempSure System | Cynosure, LLC | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 3 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 4 | 0 |
| 2020 | 4 | 0 |
| 2021 | 4 | 0 |
| 2022 | 3 | 0 |
| 2023 | 8 | 0 |
| 2024 | 6 | 0 |
| 2025 | 5 | 0 |
| 2026 | 6 | 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 |
|---|---|---|---|
| * | K122389 | TrusculptSummary page 1…Massager, Vacuum, Radio Frequency Induced Heat, PBX, 878.4400 Legally Marketed Predicate truScuipt (Cuter6 K 1223 89) Device(s): Device Description: The device is a hand-held RIF probe with integrated massaging head. The device is activated usi… | 2012 |
What descends from it? (48)
See all 484 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
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. 2014, 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 PelleFirm RF device is intended to provide heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation.
The PelleFirm massage device is intended to provide a temporary reduction in the appearance of cellulite.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132949 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132949: Pellefirm.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132949
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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