510(k) · Cleared
ClearedNix Ultra Lice Treatment Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtech Products, Inc. · LJL Detectors And Removers, Lice, (Including Combs)
Cleared on Mar 21, 2017 as substantially equivalent to K981147 (Care Technologies, Inc., 1998) after a 106-day review. Its family tree reaches back 2 generations to 1982.
- Decided
- Mar 21, 2017
- Review
- 106 days
- Class
- Class I
- Product code
- LJL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K822421 (1982). 3 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K822421 | Innocomb Lice Comb | Innovative Products, Inc. | 1982 | — |
| −1 | K981147 | Clear (TM) Lice Egg Remover System | Care Technologies, Inc. | 1998 | — |
| 0 (this device) | K163401 | Nix Ultra Lice Treatment Kit | Medtech Products, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 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 LJL? 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
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 |
|---|---|---|---|
| * | K981147 | Clear (TM) Lice Egg Remover SystemSummary page 5…5-1 5. Legally Marketed Predicate Device Clear™ Lice Egg Remover System (K981147), Product Code LJL 6. Device Description The Nix® Ultra Lice Treatment Kit consists of two components: Nix® Ultra Lice Kill… | 1998 |
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 35 years and passes through 3 companies; a new generation was cleared every 18.8 years on median.
- None of the 3 ancestors has a recall.
- 1 other device also cites its predicate K981147.
How does its category compare?
All LJL devicesLJL Detectors And Removers, Lice, (Including Combs): FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · LJL
2in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · LJL
Too few LJL 510(k)s in any year since 2007 to give a median.
Recalls per year · LJL
No recall names LJL since 2007.
Adverse event reports per year · LJL
2in 2024
MAUDE reports naming product code LJL, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 2 | — | 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 | 2 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Nix® Ultra Lice Treatment Kit is intended to kill and remove head lice and their eggs from adults and children two years of age or older.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K163401 · printed Nov 5, 2026
Cite this page
510(k) Report. “K163401: Nix Ultra Lice Treatment Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K163401
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