510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K031788Substantially Equivalent

Pathfinder

Massie Research Laboratories, Inc., Pleasanton CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K031788 is the FDA 510(k) clearance record for PATHFINDER, a class II device, cleared for Massie Research Laboratories, Inc. on under FDA product code MXK (Device, Analysis, Anterior Segment). FDA records list 2 510(k) clearances for Massie Research Laboratories, Inc., from to . As of , FDA records show no recalls naming K031788.

Clearance record

Decision date
Received
(450 days to decision)
Product code
MXK Device, Analysis, Anterior Segment
Regulation
21 CFR 886.1850
Device class
Class II
Review panel
Ophthalmic
Applicant
Massie Research Laboratories, Inc. 5775 W. Los Positas, Pleasanton CA
510(k) summary
Statement
Third party review
No

Clearances, product code MXK

Trailing 12 months
2 clearances under product code MXK in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code MXK, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20261
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260