510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K881201Substantially Equivalent

Hr Vacutrac

Abbott Medical, Mission Viejo CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K881201 is the FDA 510(k) clearance record for HR VACUTRAC, a class II device, cleared for Icu Medical, Inc. on under FDA product code JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection). FDA records list 1,478 510(k) clearances for Abbott Medical, from to . As of , FDA records show no recalls naming K881201.

Clearance record

Decision date
Received
(56 days to decision)
Product code
JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Regulation
21 CFR 862.1675
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Icu Medical, Inc. 23436 Madero St., Mission Viejo CA
Third party review
No

Clearances, product code JKA

Trailing 12 months
7 clearances under product code JKA in the twelve months to October 2026, April 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code JKA, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20261
April 20263
May 20260
June 20261
July 20260
August 20260
September 20261
October 20261