510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K260396Substantially Equivalent

KCS rTMS Therapy System (Transcranial Magnetic Stimulator) (MetaStim 100, MetaStim 100A)

Fidelity BioPharma Co., New Haven CT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

Clearance record

Decision date
Received
(212 days to decision)
Product code
OBP Transcranial Magnetic Stimulator
Regulation
21 CFR 882.5805
Device class
Class II
Review panel
Neurology
Applicant
Fidelity BioPharma Co. 157 Church St., Suite 1915, New Haven CT
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OBP

Trailing 12 months
9 clearances under product code OBP in the twelve months to October 2026, March 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code OBP, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20261
March 20262
April 20260
May 20262
June 20260
July 20260
August 20262
September 20261
October 20260