510(k) · Cleared
ClearedBMR Face
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio-Medical Research, Ltd. · NFO Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Cleared on Nov 10, 2011 as substantially equivalent to K011935 (Salton, Inc., 2001) after a 394-day review. Its family tree reaches back 1 generation to 2001. 5 later devices descend from it.
- Decided
- Nov 10, 2011
- Review
- 394 days
- Class
- Class II
- Product code
- NFO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K011935 (2001). 5 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK011935 Rejuvenique Model #RJV10Salton, Inc. · 2001
- This deviceK103031 BMR FaceBio-Medical Research, Ltd. · 2011
- Descendant · cites it directly · 1 of its ownK250227 JOVS Electric Stimulation Beauty Device (JE2)Shenzhen Qianyu Technology Co., Ltd. · 2025
- Descendant · cites it directly · 1 of its ownK244004 Microcurrent Facial Device (CEC101, EE0101, EEI101)Shenzhen Dachi Communication Co., Ltd. · 2025
- Descendant · 2 generations on · 0 of its ownK253932 FACEGYM Pro Device (HD-109)Shenzhen Kaiyan Medical Equipment Co., Ltd. · 2026
- Descendant · 2 generations on · 0 of its ownK252553 Facial & Body Beauty Device (INIA-BD001, INIA-BD002, INIA-BD003…Shenzhen Jianchao Intelligent Technology Co., Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK192077 Tua Face Fitness / Tua Trend FaceVupiesse S.R.L · 2020
Most influential descendants
Showing 5 of 5 · See all- K250227JOVS Electric Stimulation Beauty Device (JE2)Shenzhen Qianyu Technology Co., Ltd. · 2025 · cites it directly1descendant
- K244004Microcurrent Facial Device (CEC101, EE0101, EEI101)Shenzhen Dachi Communication Co., Ltd. · 2025 · cites it directly1descendant
- K253932FACEGYM Pro Device (HD-109)Shenzhen Kaiyan Medical Equipment Co., Ltd. · 2026 · 2 generations on0descendants
- K252553Facial & Body Beauty Device (INIA-BD001, INIA-BD002, INIA-BD003, INIA-BD004, F2C15…Shenzhen Jianchao Intelligent Technology Co., Ltd. · 2025 · 2 generations on0descendants
- K192077Tua Face Fitness / Tua Trend FaceVupiesse S.R.L · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K011935 | Rejuvenique Model #RJV10 | Salton, Inc. | 2001 | — |
| 0 (this device) | K103031 | BMR Face | Bio-Medical Research, Ltd. | 2011 | — |
| +1 | K250227 | JOVS Electric Stimulation Beauty Device (JE2) | Shenzhen Qianyu Technology Co., Ltd. | 2025 | — |
| +1 | K244004 | Microcurrent Facial Device (CEC101, EE0101, EEI101) | Shenzhen Dachi Communication Co., Ltd. | 2025 | — |
| +2 | K253932 | FACEGYM Pro Device (HD-109) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2026 | — |
| +2 | K252553 | Facial & Body Beauty Device (INIA-BD001, INIA-BD002, INIA-BD003, INIA-BD004… | Shenzhen Jianchao Intelligent Technology Co., Ltd. | 2025 | — |
| +1 | K192077 | Tua Face Fitness / Tua Trend Face | Vupiesse S.R.L | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2025 | 3 | 0 |
| 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 NFO? 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 NFO device
- #1 K233010 Beagank 4T Plusscore 28.6 · 5 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 |
|---|---|---|---|
| * | K011935 | Rejuvenique Model #RJV10Summary page 4…-1 & IEC 60601-2-10 Ref: KOI 1935 Chemicat Safety MSDS Sheet provided for conductive gel pads Ret: K01 1935 Desitn Device contaitss a eotstrol utnit, applicator, gel pads, charger =ad Device contains a control un… | 2001 |
What descends from it? (5)
3 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 NFO devicesNFO Stimulator, Transcutaneous Electrical, Aesthetic Purposes: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · NFO
16in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NFO
124in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NFO
2in 2012
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NFO
4in 2025
MAUDE reports naming product code NFO, 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 | 1 | — | 0 | 0 |
| 2008 | 3 | 550 | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 3 | 394 | 0 | 1 |
| 2012 | 3 | 160 | 2 | 0 |
| 2013 | 2 | — | 0 | 1 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 2 | — | 0 | 1 |
| 2016 | 2 | — | 0 | 5 |
| 2017 | 7 | 189 | 0 | 0 |
| 2018 | 5 | 177 | 0 | 0 |
| 2019 | 3 | 149 | 0 | 1 |
| 2020 | 2 | — | 0 | 6 |
| 2021 | 7 | 210 | 0 | 6 |
| 2022 | 2 | — | 0 | 5 |
| 2023 | 8 | 128 | 0 | 1 |
| 2024 | 5 | 109 | 0 | 4 |
| 2025 | 16 | 124 | 0 | 4 |
| 2026 | 8 | 153 | 0 | — |
What is it indicated for?
BMR Face is intended for facial stimulation and is indicated for over the counter
cosmetic use
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103031 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103031: BMR Face.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103031
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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