510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K981037Substantially Equivalent

Clear (Tm) Special Nit Comb

Care Technologies, Inc., Washington DC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K981037 is the FDA 510(k) clearance record for CLEAR (TM) SPECIAL NIT COMB, a class I device, cleared for Care Technologies, Inc. on under FDA product code LJL (Detectors And Removers, Lice, (Including Combs)). FDA records list 2 510(k) clearances for Care Technologies, Inc., from to . As of , FDA records show no recalls naming K981037.

Clearance record

Decision date
Received
(64 days to decision)
Product code
LJL Detectors And Removers, Lice, (Including Combs)
Regulation
21 CFR 880.5960
Device class
Class I
Review panel
General Hospital
Applicant
Care Technologies, Inc. 2000 M St. NW (#700), Washington DC
510(k) summary
Summary
Third party review
No

Clearances, product code LJL

Trailing 12 months

FDA records hold no clearances under product code LJL in the trailing twelve months.

FDA records show no clearances under product code LJL in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LJL, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260