510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K040213Substantially Equivalent

Mhlx7ec Transducer

Microhelix, Inc., Bainbridge Island WA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K040213 is the FDA 510(k) clearance record for MHLX7EC TRANSDUCER, a class II device, cleared for Microhelix, Inc. on under FDA product code ITX (Transducer, Ultrasonic, Diagnostic). FDA records list one 510(k) clearance for Microhelix, Inc. As of , FDA records show no recalls naming K040213.

Clearance record

Decision date
Received
(236 days to decision)
Product code
ITX Transducer, Ultrasonic, Diagnostic
Regulation
21 CFR 892.1570
Device class
Class II
Review panel
Radiology
Applicant
Microhelix, Inc. 13221 NE Teem Loop Rd., Bainbridge Island WA
510(k) summary
Summary PDF
Third party review
Yes

Clearances, product code ITX

Trailing 12 months
6 clearances under product code ITX in the twelve months to October 2026, July 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code ITX, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20263
August 20262
September 20261
October 20260