510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K020800Substantially Equivalent

Optax System

Optax Systems, Inc., Hopkonton MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K020800 is the FDA 510(k) clearance record for OPTAX SYSTEM, cleared for Optax Systems, Inc. on under FDA product code LQD (Recorder, Attention Task Performance). FDA records list one 510(k) clearance for Optax Systems, Inc. As of , FDA records show no recalls naming K020800.

Clearance record

Decision date
Received
(90 days to decision)
Product code
LQD Recorder, Attention Task Performance
Device class
Unclassified
Review panel
Unknown
Applicant
Optax Systems, Inc. 7 Tiffany Trl., Hopkonton MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LQD

Trailing 12 months

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

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