510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K243891Substantially Equivalent

EarliPoint System

Earlitec Diagnostics, Atlanta GA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K243891 is the FDA 510(k) clearance record for EarliPoint System, a class II device, cleared for Earlitec Diagnostics on under FDA product code QPF (Pediatric Autism Spectrum Disorder Diagnosis Aid). FDA's definition for product code QPF reads: "A pediatric Autism Spectrum Disorder diagnosis aid is a prescription device that is intended for use as an aid in the diagnosis of Autism Spectrum Disorder in pediatric patients". FDA records list 4 510(k) clearances for Earlitec Diagnostics, from to . As of , FDA records show no recalls naming K243891.

Clearance record

Decision date
Received
(98 days to decision)
Product code
QPF Pediatric Autism Spectrum Disorder Diagnosis Aid
Regulation
21 CFR 882.1491
Device class
Class II
Review panel
Neurology
Applicant
Earlitec Diagnostics 755 Commerce Dr., Suite 700, Atlanta GA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QPF

Trailing 12 months
1 clearance under product code QPF in the twelve months to October 2026, March 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code QPF, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20261
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260