510(k) Report

510(k) · Cleared

Cleared

Innocomb Lice Comb

K822421510(k) TraditionalCleared Oct 13, 198258-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

Innovative Products, Inc. · LJL Detectors And Removers, Lice, (Including Combs)

Cleared on Oct 13, 1982 after a 58-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it.

Decided
Oct 13, 1982
Review
58 days
Class
Class I
Product code
LJL
Recalls
None
Predicates
0

4 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 1998: 2 descendants cleared2017: 1 descendant cleared1999: 1 descendant cleared19801990200020102020
  1. This deviceK822421 Innocomb Lice CombInnovative Products, Inc. · 1982
  2. Descendant · cites it directly · 2 of its ownK981147 Clear (TM) Lice Egg Remover SystemCare Technologies, Inc. · 1998
  3. Descendant · 2 generations on · 0 of its ownK163401 Nix Ultra Lice Treatment KitMedtech Products, Inc. · 2017
  4. Descendant · 2 generations on · 0 of its ownK991958 Klout Shampoo and Lice Combing Pretreatment KitKiel Laboratories, Inc. · 1999
  5. Descendant · cites it directly · 0 of its ownK981037 Clear (TM) Special Nit CombCare Technologies, Inc. · 1998

Most influential descendants

Showing 4 of 4 · See all
  • K981147Clear (TM) Lice Egg Remover SystemCare Technologies, Inc. · 1998 · cites it directly2descendants
  • K163401Nix Ultra Lice Treatment KitMedtech Products, Inc. · 2017 · 2 generations on0descendants
  • K991958Klout Shampoo and Lice Combing Pretreatment KitKiel Laboratories, Inc. · 1999 · 2 generations on0descendants
  • K981037Clear (TM) Special Nit CombCare Technologies, Inc. · 1998 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K822421Innocomb Lice CombInnovative Products, Inc.1982—
+1K981147Clear (TM) Lice Egg Remover SystemCare Technologies, Inc.1998—
+2K163401Nix Ultra Lice Treatment KitMedtech Products, Inc.2017—
+2K991958Klout Shampoo and Lice Combing Pretreatment KitKiel Laboratories, Inc.1999—
+1K981037Clear (TM) Special Nit CombCare Technologies, Inc.1998—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199820
199910
201710
FIG. 1 — Lineage of K822421, 1982–2017Source: 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), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (4)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K981147Clear (TM) Lice Egg Remover SystemCare Technologies, Inc.19982
K981037Clear (TM) Special Nit CombCare Technologies, Inc.19980

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?

  • Of its descendants, K981147 (Care Technologies, Inc., 1998) has gone furthest, with 2 descendants of its own.

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

2009: 22017: 2
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

2018: 12020: 12023: 12024: 2
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20092—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20172—00
20180—01
20190—00
20200—01
20210—00
20220—00
20230—01
20240—02
20250—00
20260—0—

More from Innovative Products, Inc.

3 FDA decisions under this applicant name. See the company

  • K071390Wheelchair Model STSInnovative Products, Inc. · 2007
  • K790572Lounge, Tilt-a-Body StretchInnovative Products, Inc. · 1979

Recent decisions in LJL

The LJL category page

  • K151562Resultz Lice & Egg Removal KitPiedmont Pharmaceuticals, LLC · 2017
  • K163401Nix Ultra Lice Treatment KitMedtech Products, Inc. · 2017
  • K093144LousebusterLarada Sciences · 2009
  • K083206LousebusterLarada Sciences · 2009
  • K991958Klout Shampoo and Lice Combing Pretreatment KitKiel Laboratories, Inc. · 1999

https://510kreport.com/device/K822421 · printed Nov 6, 2026

Cite this page

510(k) Report. “K822421: Innocomb Lice Comb.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K822421

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026