510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K181672Substantially Equivalent

SureTouch Mobile Pressure Mapping System

Sure, Inc., Palos Verdes Estates CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K181672 is the FDA 510(k) clearance record for SureTouch Mobile Pressure Mapping System, a class II device, cleared for Sure, Inc. on under FDA product code NKA (System, Documentation, Breast Lesion). FDA's definition for product code NKA reads: "A Breast lesion documentation device is a device for recording and documenting palpable breast lesions detected during a clinical breast exam". FDA records list one 510(k) clearance for Sure, Inc. As of , FDA records show no recalls naming K181672.

Clearance record

Decision date
Received
(368 days to decision)
Product code
NKA System, Documentation, Breast Lesion
Regulation
21 CFR 884.2990
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Sure, Inc. 1404 Granvia Altamira, Palos Verdes Estates CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NKA

Trailing 12 months

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

FDA records show no clearances under product code NKA in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NKA, 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