510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K894103Substantially Equivalent

Scimed Ultrox True Membrane Oxygen Syst, Ultrox II

Scimed Life Systems, Inc., Plymouth MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K894103 is the FDA 510(k) clearance record for SCIMED ULTROX TRUE MEMBRANE OXYGEN SYST, ULTROX II, a class II device, cleared for Scimed Life Systems, Inc. on under FDA product code DTZ (Oxygenator, Cardiopulmonary Bypass). FDA records list 109 510(k) clearances for Scimed Life Systems, Inc., from to . As of , FDA records show no recalls naming K894103.

Clearance record

Decision date
Received
(104 days to decision)
Product code
DTZ Oxygenator, Cardiopulmonary Bypass
Regulation
21 CFR 870.4350
Device class
Class II
Review panel
Cardiovascular
Applicant
Scimed Life Systems, Inc. 2905 Northwest Blvd., Plymouth MN
Third party review
No

Clearances, product code DTZ

Trailing 12 months
4 clearances under product code DTZ in the twelve months to November 2026, March 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code DTZ, trailing twelve months
MonthClearances
December 20251
January 20260
February 20260
March 20262
April 20260
May 20260
June 20260
July 20260
August 20260
September 20261
October 20260
November 20260