510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K915752Substantially Equivalent

First Touch/viledon Non-Woven Filter

First Touch Disposables, Inc., Wilmington NC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K915752 is the FDA 510(k) clearance record for FIRST TOUCH/VILEDON NON-WOVEN FILTER, a class II device, cleared for First Touch Disposables, Inc. on under FDA product code FMZ (Incubator, Neonatal). FDA records list 2 510(k) clearances for First Touch Disposables, Inc., from to . As of , FDA records show no recalls naming K915752.

Clearance record

Decision date
Received
(269 days to decision)
Product code
FMZ Incubator, Neonatal
Regulation
21 CFR 880.5400
Device class
Class II
Review panel
General Hospital
Applicant
First Touch Disposables, Inc. 3342 Wrightville Ave., Wilmington NC
510(k) summary
Statement
Third party review
No

Clearances, product code FMZ

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