510(k) · Cleared
ClearedDeka Tiac II
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
El.En Electronic Engineering Spa · PBX Massager, Vacuum, Radio Frequency Induced Heat
Cleared on Oct 15, 2021 as substantially equivalent to K183371 (El..En. Electroic Engineering Spa, 2019) after a 186-day review. Its family tree reaches back 4 generations to 2012. 1 later device descends from it.
- Decided
- Oct 15, 2021
- Review
- 186 days
- Class
- Class II
- Product code
- PBX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K122389 (2012). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK122389 TrusculptCutera, Inc. · 2012 · Recalled
- 3 generations backK132949 PellefirmEllman International, Inc. · 2014
- 2 generations backK143040 Exilis XPBTL Industries, Inc. · 2015
- 1 generation backK183371 Deka Tiac 1El..En. Electroic Engineering Spa · 2019
- This deviceK211091 Deka Tiac IIEl.En Electronic Engineering Spa · 2021
- Descendant · cites it directly · 0 of its ownK260647 SpecchioEl.En S.P.A. · 2026
Most influential descendants
Showing 1 of 1 · See all- K260647SpecchioEl.En S.P.A. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K122389 | Trusculpt | Cutera, Inc. | 2012 | 1 |
| −3 | K132949 | Pellefirm | Ellman International, Inc. | 2014 | — |
| −2 | K143040 | Exilis XP | BTL Industries, Inc. | 2015 | — |
| −1 | K183371 | Deka Tiac 1 | El..En. Electroic Engineering Spa | 2019 | — |
| 0 (this device) | K211091 | Deka Tiac II | El.En Electronic Engineering Spa | 2021 | — |
| +1 | K260647 | Specchio | El.En S.P.A. | 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 |
|---|---|---|---|
| * | K183371 | Deka Tiac 1Summary page 4…massage device Classification Name: Massager, vacuum, radio frequency induced heat (PBX) Classification Number: 21 CFR 878.4400 Predicate Devices: DEKA TIAC 1 (K183371) 1/5… | 2019 |
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 |
|---|---|---|---|
| K260647 | Specchio | 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 9 years and passes through 5 companies; a new generation was cleared every 1.9 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K260647 (El.En S.P.A., 2026) has gone furthest, with 0 descendants of its own.
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. 2021, 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 DEKA TIAC II 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 DEKA TIAC II 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/K211091 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211091: Deka Tiac II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211091
Report an extraction error
Are you the manufacturer?
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