510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
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K023161Substantially Equivalent

Smartstep System

Andante Medical Device, Ltd., Ra'Ananna 43373, IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K023161 is the FDA 510(k) clearance record for SMARTSTEP SYSTEM, a class II device, cleared for Andante Medical Device, Ltd. on under FDA product code IRN (Device, Warning, Overload, External Limb, Powered). FDA records list one 510(k) clearance for Andante Medical Device, Ltd. As of , FDA records show no recalls naming K023161.

Clearance record

Decision date
Received
(78 days to decision)
Product code
IRN Device, Warning, Overload, External Limb, Powered
Regulation
21 CFR 890.5575
Device class
Class II
Review panel
Physical Medicine
Applicant
Andante Medical Device, Ltd. 117 Ahuzah St., Ra'Ananna 43373, IL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code IRN

Trailing 12 months

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

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