510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K901309Substantially Equivalent

Sylvan Pediascan 200 Transilluminator

Sylvan Corp., Irwin PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K901309 is the FDA 510(k) clearance record for SYLVAN PEDIASCAN 200 TRANSILLUMINATOR, a class I device, cleared for Sylvan Corp. on under FDA product code HJN (Transilluminator, Battery-Powered). FDA records list one 510(k) clearance for Sylvan Corp. As of , FDA records show no recalls naming K901309.

Clearance record

Decision date
Received
(65 days to decision)
Product code
HJN Transilluminator, Battery-Powered
Regulation
21 CFR 886.1945
Device class
Class I
Review panel
Ophthalmic
Applicant
Sylvan Corp. P.O. Box 362,, Irwin PA
Third party review
No

Clearances, product code HJN

Trailing 12 months

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

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