510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K853257Substantially Equivalent

Speculite Disposable Vaginal Light

Trylon Associates, Ltd., Harbor City CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K853257 is the FDA 510(k) clearance record for SPECULITE DISPOSABLE VAGINAL LIGHT, a class II device, cleared for Trylon Associates, Ltd. on under FDA product code HIC (Speculum, Vaginal, Nonmetal, Fiberoptic). FDA records list one 510(k) clearance for Trylon Associates, Ltd. As of , FDA records show no recalls naming K853257.

Clearance record

Decision date
Received
(147 days to decision)
Product code
HIC Speculum, Vaginal, Nonmetal, Fiberoptic
Regulation
21 CFR 884.4530
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Trylon Associates, Ltd. 26214 Athena Ave., Harbor City CA
Third party review
No

Clearances, product code HIC

Trailing 12 months

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

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