510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K940812Substantially Equivalent

Insight Electronic Alignment Indicator

Andronic Devices, Ltd., Richmond, B.C. Canada V6v 2j2, CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K940812 is the FDA 510(k) clearance record for INSIGHT ELECTRONIC ALIGNMENT INDICATOR, a class I device, cleared for Andronic Devices, Ltd. on under FDA product code KQX (Goniometer, Ac-Powered). FDA records list 16 510(k) clearances for Andronic Devices, Ltd., from to . As of , FDA records show no recalls naming K940812.

Clearance record

Decision date
Received
(272 days to decision)
Product code
KQX Goniometer, Ac-Powered
Regulation
21 CFR 888.1500
Device class
Class I
Review panel
Orthopedic
Applicant
Andronic Devices, Ltd. Suite 140, Richmond, B.C. Canada V6v 2j2, CA
510(k) summary
Summary
Third party review
No

Clearances, product code KQX

Trailing 12 months

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

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