510(k) · Cleared
ClearedBarf Band
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Doodlebug Products, LLC · MVV Device, Acupressure
Cleared on Feb 27, 2012 as substantially equivalent to K070766 (Psi Health Solutions, Inc., 2007) and 1 other predicate after a 340-day review. Its family tree reaches back 10 generations to 1997.
- Decided
- Feb 27, 2012
- Review
- 340 days
- Class
- Class U
- Product code
- MVV
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K961050 (1997). 14 ancestors in all, the oldest K900588 (1990). No later device cites it as a predicate yet.
- Root · 10 generations backK961050 Reliefband Tens Unit (Modification)Maven Labs, Inc. · 1997
- 6 generations between
- 3 generations backK051397 BiobandsBiobands Distributors, Inc. · 2005
- 2 generations backK053509 Acuband Acupressure Wrist Band DeviceAcuband, Inc. · 2006
- 1 generation backK070766 Psi BandsPsi Health Solutions, Inc. · 2007 · Recalled
- This deviceK110821 Barf BandDoodlebug Products, LLC · 2012
Show all 10 generations
- Root · 10 generations backK961050 Reliefband Tens Unit (Modification)Maven Labs, Inc. · 1997
- 9 generations backK980333 ReliefbandWoodside Biomedical, Inc. · 1998
- 8 generations backK982436 Reliefband NST Device, Model #'S WB-2, WB-6 and WB-RWoodside Biomedical, Inc. · 1998
- 7 generations backK994387 Reliefband NST Device, Model WB-2L, WB-6L, WB-RLWoodside Biomedical, Inc. · 2000
- 6 generations backK020180 Reliefband Device, Models RB-DL, RB-EL, RB-RLWoodside Biomedical, Inc. · 2002
- 5 generations backK033268 Sea-BandSea-Band UK, Ltd. · 2004
- 4 generations backK041877 Acu-Strap Motion Sickness BandHealth Ent., Inc. · 2004
- 3 generations backK051397 BiobandsBiobands Distributors, Inc. · 2005
- 2 generations backK053509 Acuband Acupressure Wrist Band DeviceAcuband, Inc. · 2006
- 1 generation backK070766 Psi BandsPsi Health Solutions, Inc. · 2007 · Recalled
- This deviceK110821 Barf BandDoodlebug Products, LLC · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K961050 | Reliefband Tens Unit (Modification) | Maven Labs, Inc. | 1997 | — |
| −9 | K980333 | Reliefband | Woodside Biomedical, Inc. | 1998 | — |
| −8 | K982436 | Reliefband NST Device, Model #'S WB-2, WB-6 and WB-R | Woodside Biomedical, Inc. | 1998 | — |
| −7 | K994387 | Reliefband NST Device, Model WB-2L, WB-6L, WB-RL | Woodside Biomedical, Inc. | 2000 | — |
| −6 | K020180 | Reliefband Device, Models RB-DL, RB-EL, RB-RL | Woodside Biomedical, Inc. | 2002 | — |
| −5 | K033268 | Sea-Band | Sea-Band UK, Ltd. | 2004 | — |
| −4 | K041877 | Acu-Strap Motion Sickness Band | Health Ent., Inc. | 2004 | — |
| −3 | K051397 | Biobands | Biobands Distributors, Inc. | 2005 | — |
| −2 | K053509 | Acuband Acupressure Wrist Band Device | Acuband, Inc. | 2006 | — |
| −1 | K070766 | Psi Bands | Psi Health Solutions, Inc. | 2007 | 1 |
| 0 (this device) | K110821 | Barf Band | Doodlebug Products, LLC | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1999 | 2 | 0 |
| 2004 | 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 MVV? 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 MVV device
- #1 K193374 TumEase Acupressure Braceletsscore 7.0 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K070766 | Psi BandsSummary page 2…point. The cotton isused inside the band to make the band comfortable to the end user. Substantial Equivalence The Bar? Band isas safe and effective as the PSI Band-(K070766) and Sea Band (K(033268). The Bar?' Band has the same intended uses and indications for use, similar technological characteristic… | 2007 |
| * | K033268 | Sea-BandSummary page 2…inside the band to make the band comfortable to the end user. Substantial Equivalence The Bar? Band isas safe and effective as the PSI Band-(K070766) and Sea Band (K(033268). The Bar?' Band has the same intended uses and indications for use, similar technological characteristics, and same principles o… | 2004 |
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 15 years and passes through 8 companies; a new generation was cleared every 11 months on median.
- 1 of the 14 ancestors has a recall of any class.
How does its category compare?
All MVV devicesMVV Device, Acupressure: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · MVV
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · MVV
Too few MVV 510(k)s in any year since 2007 to give a median.
Recalls per year · MVV
1in 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MVV
1in 2024
MAUDE reports naming product code MVV, 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 | — | 1 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Badf Band is indicated for the relief of nausea. Nausea is a symptom that may be experienced due to a variety of causes, for example: pregnancy (morning sickness), motion sickness, anesthesia and chemotherapy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110821 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110821: Barf Band.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110821
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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