510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
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K122800Substantially Equivalent

Inner Peace

Kamabry, Inc., dba Inner Peace for Women, Crofton MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K122800 is the FDA 510(k) clearance record for INNER PEACE, a class II device, cleared for Kamabry, Inc., Dba Inner Peace For Women on under FDA product code HIR (Perineometer). FDA records list one 510(k) clearance for Kamabry, Inc., Dba Inner Peace For Women. As of , FDA records show no recalls naming K122800.

Clearance record

Decision date
Received
(387 days to decision)
Product code
HIR Perineometer
Regulation
21 CFR 884.1425
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Kamabry, Inc., Dba Inner Peace For Women 1468 Harwell Have, Crofton MD
510(k) summary
Summary PDF
Third party review
No

Clearances, product code HIR

Trailing 12 months
1 clearance under product code HIR 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 HIR, 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 20260
October 20260