510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K100576Substantially Equivalent

High Pressure Sets-400 Psi

Abbott Medical, Salt Lake City UT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K100576 is the FDA 510(k) clearance record for HIGH PRESSURE SETS-400 PSI, a class II device, cleared for Icu Medical, Inc. on under FDA product code FPA (Set, Administration, Intravascular). FDA records list 1,478 510(k) clearances for Abbott Medical, from to . As of , FDA records show 7 recalls naming K100576.

Clearance record

Decision date
Received
(291 days to decision)
Product code
FPA Set, Administration, Intravascular
Regulation
21 CFR 880.5440
Device class
Class II
Review panel
General Hospital
Applicant
Icu Medical, Inc. 4455 Atherton Dr., Salt Lake City UT
510(k) summary
Summary PDF
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