510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K895609Substantially Equivalent

Pupil Pathway Analyzer (Ppa)

Pulse Medical Instruments, Costa Mesa CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K895609 is the FDA 510(k) clearance record for PUPIL PATHWAY ANALYZER (PPA), a class I device, cleared for Pulse Medical Instruments on under FDA product code HLG (Pupillometer, Ac-Powered). FDA records list one 510(k) clearance for Pulse Medical Instruments. As of , FDA records show no recalls naming K895609.

Clearance record

Decision date
Received
(45 days to decision)
Product code
HLG Pupillometer, Ac-Powered
Regulation
21 CFR 886.1700
Device class
Class I
Review panel
Ophthalmic
Applicant
Pulse Medical Instruments 130 Mccormick Ave., Costa Mesa CA
Third party review
No

Clearances, product code HLG

Trailing 12 months

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

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