510(k) Report

De Novo · Granted

Granted

Piezo-Electric Stimulator For Relief Of Mosquito Bite Itch

DEN100024De NovoClass II21 CFR 882.5894

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Unknown applicant · OSG Piezo-Electric Stimulator For Relief Of Mosquito Bite Itch

Granted as a new device type through De Novo. 47 later devices descend from it.

Class
Class II
Product code
OSG
Recalls
None

47 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2003: 1 descendant cleared2006: 2 descendants cleared2007: 3 descendants cleared2012: 4 descendants cleared2013: 3 descendants cleared2020: 4 descendants cleared2014: 3 descendants cleared2010: 1 descendant cleared2009: 2 descendants cleared2008: 4 descendants cleared2021: 2 descendants cleared2024: 5 descendants cleared2015: 2 descendants cleared2019: 3 descendants cleared2017: 1 descendant cleared2022: 2 descendants cleared2025: 4 descendants cleared2026: 1 descendant cleared
  1. This deviceDEN100024 Piezo-Electric Stimulator For Relief Of Mosquito Bite Itch ·
  2. Descendant · cites it directly · 46 of its ownK022809 EZ Splint & EZ Splint PMPower Products, Inc.-Splintek · 2003
  3. Descendant · 2 generations on · 19 of its ownK072147 Den Tek Comfort Fit NightguardDen Tek Oral Care, Inc. · 2007
  4. Descendant · 2 generations on · 9 of its ownK123161 Smartguard Night Guard, Smartguard Original, Smartguard Night Guard…Smartguard, Inc. · 2013
  5. Descendant · 3 generations on · 8 of its ownK082301 Grind NO MorePlacontrol, Inc. · 2008
  6. Descendant · 2 generations on · 7 of its ownK063229 Rest Assured Nite ProtectorRanir, LLC · 2006

Showing 5 of 47 descendants. See all descendants

Descendants cleared per year

2003: 12006: 22007: 32008: 42009: 22010: 12012: 42013: 32014: 32015: 22017: 12019: 32020: 42021: 22022: 22024: 52025: 42026: 1
2003high 5 (2024) · low 0 (2004)2026

Most influential descendants

Showing 5 of 47 · See all
  • K022809EZ Splint & EZ Splint PMPower Products, Inc.-Splintek · 2003 · cites it directly46descendants
  • K072147Den Tek Comfort Fit NightguardDen Tek Oral Care, Inc. · 2007 · 2 generations on19descendants
  • K123161Smartguard Night Guard, Smartguard Original, Smartguard Night Guard Original, Smartguard…Smartguard, Inc. · 2013 · 2 generations on9descendants
  • K082301Grind NO MorePlacontrol, Inc. · 2008 · 3 generations on8descendants
  • K063229Rest Assured Nite ProtectorRanir, LLC · 2006 · 2 generations on7descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)DEN100024Piezo-Electric Stimulator For Relief Of Mosquito Bite Itch—
+1K022809EZ Splint & EZ Splint PMPower Products, Inc.-Splintek2003—
+2K072147Den Tek Comfort Fit NightguardDen Tek Oral Care, Inc.2007—
+2K123161Smartguard Night Guard, Smartguard Original, Smartguard Night Guard Original…Smartguard, Inc.2013—
+3K082301Grind NO MorePlacontrol, Inc.2008—
+2K063229Rest Assured Nite ProtectorRanir, LLC2006—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
200620
200730
200840
200920
201010
201240
201330
201430
201520
201710
201930
202040
202120
202220
202450
202540
202610
FIG. 1 — Lineage of DEN100024, –2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA De Novo database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in OSG? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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Does it have a predicate?

De Novo decisions do not claim a predicate device.

What descends from it? (47)

See all 47

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K022809EZ Splint & EZ Splint PMPower Products, Inc.-Splintek200346

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, K022809 (Power Products, Inc.-Splintek, 2003) has gone furthest, with 46 descendants of its own.

Recent decisions in OSG

The OSG category page

  • DEN130019Piezo-Electric Stimulator For Relief Of Mosquito Bite Itch

https://510kreport.com/device/DEN100024 · printed Nov 4, 2026

Cite this page

510(k) Report. “DEN100024: Piezo-Electric Stimulator For Relief Of Mosquito Bite Itch.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/DEN100024

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026