510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K162383Substantially Equivalent

Cadwell Sierra Summit, Cadwell Sierra Ascent

Cadwell Industries Inc, Kennewick WA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K162383 is the FDA 510(k) clearance record for Cadwell Sierra Summit, Cadwell Sierra Ascent, a class II device, cleared for Cadwell Industries, Inc. on under FDA product code IKN (Electromyograph, Diagnostic). FDA records list 13 510(k) clearances for Cadwell Industries, Inc., from to . As of , FDA records show no recalls naming K162383.

Clearance record

Decision date
Received
(188 days to decision)
Product code
IKN Electromyograph, Diagnostic
Regulation
21 CFR 890.1375
Device class
Class II
Review panel
Physical Medicine
Applicant
Cadwell Industries, Inc. 909 N Kellogg St., Kennewick WA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code IKN

Trailing 12 months

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

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