510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K950068Substantially Equivalent

Carbon Fiber Couch Insert

Medtec LLC, Orange City IA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K950068 is the FDA 510(k) clearance record for CARBON FIBER COUCH INSERT, a class II device, cleared for Medtec, Inc. on under FDA product code KXJ (Table, Radiologic). FDA records list 49 510(k) clearances for Medtec, Inc., from to . As of , FDA records show no recalls naming K950068.

Clearance record

Decision date
Received
(87 days to decision)
Product code
KXJ Table, Radiologic
Regulation
21 CFR 892.1980
Device class
Class II
Review panel
Radiology
Applicant
Medtec, Inc. 1401 8th St. SE, Orange City IA
510(k) summary
Statement
Third party review
No

Clearances, product code KXJ

Trailing 12 months

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

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