510(k) · Cleared
ClearedBUZZY
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mmj Labs, LLC · PHW Cold Pack And Vibrating Massager
Cleared on Aug 13, 2014 after a 523-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it.
- Decided
- Aug 13, 2014
- Review
- 523 days
- Class
- Class I
- Product code
- PHW
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK130631 BUZZYMmj Labs, LLC · 2014
- Descendant · cites it directly · 0 of its ownK202993 Buzzy® (models: Mini Healthcare, XL Healthcare, Mini Personal, XL…Mmj Labs, LLC · 2023
Most influential descendants
Showing 1 of 1 · See all- K202993Buzzy® (models: Mini Healthcare, XL Healthcare, Mini Personal, XL Personal, Pro)…Mmj Labs, LLC · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K130631 | BUZZY | Mmj Labs, LLC | 2014 | — |
| +1 | K202993 | Buzzy® (models: Mini Healthcare, XL Healthcare, Mini Personal, XL Personal… | Mmj Labs, LLC | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in PHW? 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 PHW device
- #1 K202993 Buzzy® (models: Mini Healthcare, XL…score 5.3 · 1 generation · no Class I recall
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
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 |
|---|---|---|---|
| K202993 | Buzzy® (models: Mini Healthcare, XL Healthcare, Mini Personal, XL Personal, Pro)… | 2023 | 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?
- Of its descendants, K202993 (Mmj Labs, LLC, 2023) has gone furthest, with 0 descendants of its own.
How does its category compare?
All PHW devicesPHW Cold Pack And Vibrating Massager: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · PHW
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · PHW
Too few PHW 510(k)s in any year since 2007 to give a median.
Recalls per year · PHW
No recall names PHW since 2007.
Adverse event reports per year · PHW
No MAUDE report names PHW since 2007.
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 | 0 | — | 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 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Control pain associated with injections, venipuncture, IV starts, cosmetic injections and the temporary relief of minor injuries (muscle or tendon aches, splinters and bee stings). Also intended to treat myofascial pain caused by trigger points, restricted motion and muscle tension
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K130631 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130631: BUZZY.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130631
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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