510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K191966Substantially Equivalent

NewPrim System

BRM Extremities SRL, Milano MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K191966 is the FDA 510(k) clearance record for NewPrim System, a class II device, cleared for Brm Extremities on under FDA product code KWH (Prosthesis, Toe, Constrained, Polymer). FDA records list 4 510(k) clearances for Brm Extremities, from to . As of , FDA records show no recalls naming K191966.

Clearance record

Decision date
Received
(205 days to decision)
Product code
KWH Prosthesis, Toe, Constrained, Polymer
Regulation
21 CFR 888.3720
Device class
Class II
Review panel
Orthopedic
Applicant
Brm Extremities Via Ciro Menotti 10, Milano MI
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KWH

Trailing 12 months

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

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