510(k) · Cleared

Cleared

Klout Shampoo and Lice Combing Pretreatment Kit

K991958510(k) TraditionalCleared Aug 13, 199964-day reviewClass I21 CFR 880.5960

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

Kiel Laboratories, Inc. · LJL Detectors And Removers, Lice, (Including Combs)

Cleared on Aug 13, 1999 as substantially equivalent to K981147 (Care Technologies, Inc., 1998) and 1 other predicate after a 64-day review. Its family tree reaches back 2 generations to 1982.

Decided: Aug 13, 1999
Review: 64 days
Class: Class I
Product code: LJL
Recalls: None
Predicates: 2

Its longest line of descent runs back 2 generations to K822421 (1982). 4 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK822421 Innocomb Lice CombInnovative Products, Inc. · 1982
1 generation backK981147 Clear (TM) Lice Egg Remover SystemCare Technologies, Inc. · 1998
This deviceK991958 Klout Shampoo and Lice Combing Pretreatment KitKiel Laboratories, Inc. · 1999

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)	K991958	Klout Shampoo and Lice Combing Pretreatment Kit	Kiel Laboratories, Inc.	1999	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1982	1	0
1998	1	0

FIG. 1 — Lineage of K991958, 1982–1999Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	K981147	Clear (TM) Lice Egg Remover System Summary page 1 …CLASS: I PANEL: GENERAL HOSPITAL PRODUCT CODE: LIL CLASSIFICATION NAME: DETECTORS AND REMOVERS, LICE (including combs) PREDICATE DEVICE: CLEAR™ LICE EGG REMOVER SYSTEM - K981147 LICEMEISTER™ COMB - K981250 DESCRIPTION AND INTENDED USE: The kit consists of two components, the comb and the combing pretreatm…	Care Technologies, Inc.	1998	—
*	K981250	Licemeister Comb Summary page 1 …TAL PRODUCT CODE: LIL CLASSIFICATION NAME: DETECTORS AND REMOVERS, LICE (including combs) PREDICATE DEVICE: CLEAR™ LICE EGG REMOVER SYSTEM - K981147 LICEMEISTER™ COMB - K981250 DESCRIPTION AND INTENDED USE: The kit consists of two components, the comb and the combing pretreatment shampoo. The comb is stai…	National Pediculosis Assoc.	1998	—

Also cleared against K981147: 1 other device →

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 17 years and passes through 3 companies; a new generation was cleared every 15.7 years on median.
None of the 4 ancestors has a recall.
1 other device also cites its predicate K981147.

How does its category compare?

All LJL devices

LJL 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

2007high 2 (2009) · low 0 (2007)2026

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

2007high 2 (2024) · low 0 (2007)2025

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	MAUDE reports
2007	0	—	0
2008	0	—	0
2009	2	—	0
2010	0	—	0
2011	0	—	0
2012	0	—	0
2013	0	—	0
2014	0	—	0
2015	0	—	0
2016	0	—	0
2017	2	—	0
2018	0	—	1
2019	0	—	0
2020	0	—	1
2021	0	—	0
2022	0	—	0
2023	0	—	1
2024	0	—	2
2025	0	—	0
2026	0	—	—

What is it indicated for?

the removal of head lice and their eggs (nits) from hair

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/K991958 · printed Nov 4, 2026

Cite this page

510(k) Report. “K991958: Klout Shampoo and Lice Combing Pretreatment Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K991958

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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