510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K022861Substantially Equivalent

Safetouch

Rusin Medical Devices, Anoka MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K022861 is the FDA 510(k) clearance record for SAFETOUCH, a class II device, cleared for Rusin Medical Devices on under FDA product code NHM (Sheet, Recording, Breast Examination). FDA's definition for product code NHM reads: "This recording sheet is intended to for clinicians to mark the locationof a palpable breast lump identified by a clinical breast examination". FDA records list one 510(k) clearance for Rusin Medical Devices. As of , FDA records show no recalls naming K022861.

Clearance record

Decision date
Received
(90 days to decision)
Product code
NHM Sheet, Recording, Breast Examination
Regulation
21 CFR 884.2990
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Rusin Medical Devices 3512 Rum River Dr., Anoka MN
510(k) summary
Statement
Third party review
No

Clearances, product code NHM

Trailing 12 months

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

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