510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K963391Substantially Equivalent

Speculite

Trylon Corp., Monarch Beach CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K963391 is the FDA 510(k) clearance record for SPECULITE, a class II device, cleared for Trylon Corp. on under FDA product code MPU (Source, Chemiluminescent Light). FDA records list 7 510(k) clearances for Trylon Corp., from to . As of , FDA records show one recall naming K963391.

Clearance record

Decision date
Received
(471 days to decision)
Product code
MPU Source, Chemiluminescent Light
Regulation
21 CFR 884.4530
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Trylon Corp. 23268 Atlantis Way, Monarch Beach CA
510(k) summary
Statement
Third party review
No

Clearances, product code MPU

Trailing 12 months

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

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