510(k) · Cleared
ClearedTR-100
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
BTL Industries, Inc. · PBX Massager, Vacuum, Radio Frequency Induced Heat
Cleared on Sep 13, 2016 as substantially equivalent to K143040 (BTL Industries, Inc., 2015) after a 102-day review. Its family tree reaches back 3 generations to 2012. 1 later device descends from it.
- Decided
- Sep 13, 2016
- Review
- 102 days
- Class
- Class II
- Product code
- PBX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K122389 (2012). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK122389 TrusculptCutera, Inc. · 2012 · Recalled
- 2 generations backK132949 PellefirmEllman International, Inc. · 2014
- 1 generation backK143040 Exilis XPBTL Industries, Inc. · 2015
- This deviceK161551 TR-100BTL Industries, Inc. · 2016
- Descendant · cites it directly · 0 of its ownK190023 BTL-084BTL Industries, Inc. · 2019
Most influential descendants
Showing 1 of 1 · See all- K190023BTL-084BTL Industries, Inc. · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K122389 | Trusculpt | Cutera, Inc. | 2012 | 1 |
| −2 | K132949 | Pellefirm | Ellman International, Inc. | 2014 | — |
| −1 | K143040 | Exilis XP | BTL Industries, Inc. | 2015 | — |
| 0 (this device) | K161551 | TR-100 | BTL Industries, Inc. | 2016 | — |
| +1 | K190023 | BTL-084 | BTL Industries, Inc. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 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 |
|---|---|---|---|
| * | K143040 | Exilis XPSummary page 4…ially equivalent to the current product that is already cleared for USA distribution under the following 510(k) Premarket Notification number: Exilis XP (K143040). 5-1… | 2015 |
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 |
|---|---|---|---|
| K190023 | BTL-084 | 2019 | 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 4 years and passes through 3 companies; a new generation was cleared every 1.3 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K190023 (BTL Industries, Inc., 2019) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K143040.
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. 2016, 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 TR-100 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 TR-100 massage device is intended to provide 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/K161551 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161551: TR-100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161551
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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