510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K842351Substantially Equivalent

Sterile Design-Custom Sterile IV Kit

Sterile Design, Inc., Oldsmar FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K842351 is the FDA 510(k) clearance record for STERILE DESIGN-CUSTOM STERILE IV KIT, a class II device, cleared for Sterile Design, Inc. on under FDA product code FPA (Set, Administration, Intravascular). FDA records list 10 510(k) clearances for Sterile Design, Inc., from to . As of , FDA records show no recalls naming K842351.

Clearance record

Decision date
Received
(122 days to decision)
Product code
FPA Set, Administration, Intravascular
Regulation
21 CFR 880.5440
Device class
Class II
Review panel
General Hospital
Applicant
Sterile Design, Inc. P.O. Box 12100, Oldsmar FL
Third party review
No

Clearances, product code FPA

Trailing 12 months
5 clearances under product code FPA in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code FPA, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20261
March 20260
April 20260
May 20261
June 20261
July 20260
August 20260
September 20261
October 20260