510(k) Report

510(k) · Cleared

Cleared

NailLift

K230841510(k) TraditionalCleared Jan 22, 2024300-day reviewClass U

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

Jps Corporation · MQZ Prosthesis, Nail

Cleared on Jan 22, 2024 as substantially equivalent to K162525 (Begum Saglik Hizmetleri Tibbi Malzemeler Danismanlik Lsti, 2018) after a 300-day review. Its family tree reaches back 2 generations to 1996.

Decided
Jan 22, 2024
Review
300 days
Class
Class U
Product code
MQZ
Recalls
None
Predicates
1

Its longest line of descent runs back 2 generations to K960843 (1996). No later device cites it as a predicate yet.

  1. Root · 2 generations backK960843 Stop-N-GrowEuropean Touch Co., Inc. · 1996
  2. 1 generation backK162525 Oniko nail braceBegum Saglik Hizmetleri Tibbi Malzemeler Danismanlik Lsti · 2018
  3. This deviceK230841 NailLiftJps Corporation · 2024
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K960843Stop-N-GrowEuropean Touch Co., Inc.1996—
−1K162525Oniko nail braceBegum Saglik Hizmetleri Tibbi Malzemeler Danismanlik Lsti2018—
0 (this device)K230841NailLiftJps Corporation2024—
FIG. 1 — Lineage of K230841, 1996–2024Source: 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 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.

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  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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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.

TypeNumberDeviceApplicantDecidedRecalls
*K162525Oniko nail brace
Summary page 5
…Unclassified Regulatory Class: Unclassified Product Codes: MQZ (a)(3). Predicate Device: K162525 – Oniko Nail Brace, Begum Saglik, Tibbi Malzemeler & Danismanlik Ltd Sti (a)(4). D…
Begum Saglik Hizmetleri Tibbi Malzemeler Danismanlik Lsti2018—

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 28 years and passes through 3 companies; a new generation was cleared every 21.7 years on median.
  • None of the 2 ancestors has a recall.

How does its category compare?

All MQZ devices

MQZ Prosthesis, Nail: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.

FDA decisions per year · MQZ

1in 2024

2018: 12024: 1
2007high 1 (2018) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MQZ

Too few MQZ 510(k)s in any year since 2007 to give a median.

Recalls per year · MQZ

No recall names MQZ since 2007.

Adverse event reports per year · MQZ

No MAUDE report names MQZ since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20181—00
20190—00
20200—00
20210—00
20220—00
20230—00
20241—00
20250—00
20260—0—

What is it indicated for?

NailLift is an ingrown toenail corrector that corrects nail curvature by lifting the curved toenails into a more natural shape upon application. The correction of nail curvature results in decreased pain.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K230841: NailLift.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K230841

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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