510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K100567Substantially Equivalent

Pearl Diabetes Management System

M2 Group Holdings, Inc., Sunnyvale CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K100567 is the FDA 510(k) clearance record for PEARL DIABETES MANAGEMENT SYSTEM, a class II device, cleared for M2 Group Holdings, Inc. on under FDA product code LZG (Pump, Infusion, Insulin). FDA records list one 510(k) clearance for M2 Group Holdings, Inc. As of , FDA records show no recalls naming K100567.

Clearance record

Decision date
Received
(435 days to decision)
Product code
LZG Pump, Infusion, Insulin
Regulation
21 CFR 880.5725
Device class
Class II
Review panel
General Hospital
Applicant
M2 Group Holdings, Inc. 1012 Stewart Dr., Sunnyvale CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LZG

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