510(k) · Cleared
ClearedOniko nail brace
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Begum Saglik Hizmetleri Tibbi Malzemeler Danismanlik Lsti · MQZ Prosthesis, Nail
Cleared on Apr 25, 2018 as substantially equivalent to K960843 (European Touch Co., Inc., 1996) after a 593-day review. Its family tree reaches back 1 generation to 1996. 1 later device descends from it.
- Decided
- Apr 25, 2018
- Review
- 593 days
- Class
- Class U
- Product code
- MQZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K960843 (1996). 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K230841NailLiftJps Corporation · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K960843 | Stop-N-Grow | European Touch Co., Inc. | 1996 | — |
| 0 (this device) | K162525 | Oniko nail brace | Begum Saglik Hizmetleri Tibbi Malzemeler Danismanlik Lsti | 2018 | — |
| +1 | K230841 | NailLift | Jps Corporation | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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 MQZ? 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 MQZ device
- #1 K230841 NailLiftscore 7.0 · 2 generations · no Class I recall
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 |
|---|---|---|---|
| * | K960843 | Stop-N-GrowSummary page 4…Unclassified Product code: MQZ Device Contact Class: Permanent (>30 days) Advisory Panel: General & Plastic Surgery Predicate Device: K960843- Stop-n-grow, European Touch Co., Inc. Device Description: Oniko nail brace is a device for correcting the shape for painfu… | 1996 |
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 |
|---|---|---|---|
| K230841 | NailLift | 2024 | 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?
- Its one ancestor has no recall.
- Of its descendants, K230841 (Jps Corporation, 2024) has gone furthest, with 0 descendants of its own.
How does its category compare?
All MQZ devicesMQZ Prosthesis, Nail: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · MQZ
1in 2024
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
| 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 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
To correct the shape of overcurved and/or painful nails without operation. To loosen and to give shape to thickened nails, overcurved nails and pincer nails without operation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162525 · printed Nov 4, 2026
Cite this page
510(k) Report. “K162525: Oniko nail brace.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K162525
Report an extraction error
Are you the manufacturer?
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