510(k) · Cleared
ClearedClear (TM) Special Nit Comb
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Care Technologies, Inc. · LJL Detectors And Removers, Lice, (Including Combs)
Cleared on May 22, 1998 as substantially equivalent to K822421 (Innovative Products, Inc., 1982) and 1 other predicate after a 64-day review. Its family tree reaches back 1 generation to 1982.
- Decided
- May 22, 1998
- Review
- 64 days
- Class
- Class I
- Product code
- LJL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K822421 (1982). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK822421 Innocomb Lice CombInnovative Products, Inc. · 1982
- This deviceK981037 Clear (TM) Special Nit CombCare Technologies, Inc. · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K822421 | Innocomb Lice Comb | Innovative Products, Inc. | 1982 | — |
| 0 (this device) | K981037 | Clear (TM) Special Nit Comb | Care Technologies, Inc. | 1998 | — |
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? (2)
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 |
|---|---|---|---|
| * | K822421 | Innocomb Lice CombSummary page 1…p and water after use and can withstand boiling water disinfection. The product is substantially equivalent to other nit removal combs, including the Innocomb Lice Comb (K822421) and Innomed PD-1 Kit (KB22574). The technological characteristics of the Clear Special Nit Comb are the same as other marketed… | 1982 |
| * | K822574 | Innomed PD-1 Kit | 1982 |
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?
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K822421.
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.
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?
For lice egg detection and removal
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K981037 · printed Nov 5, 2026
Cite this page
510(k) Report. “K981037: Clear (TM) Special Nit Comb.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K981037
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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