510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K812338Substantially Equivalent

Preza-Pak II, Arterial Blood Sampling Sy

Terumo Medical Corp., Elkton MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K812338 is the FDA 510(k) clearance record for PREZA-PAK II, ARTERIAL BLOOD SAMPLING SY, a class I device, cleared for Terumo Medical Corp. on under FDA product code CBT (Arterial Blood Sampling Kit). FDA's definition for product code CBT reads: "This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the...". FDA records list 157 510(k) clearances for Terumo Medical Corp., from to . As of , FDA records show no recalls naming K812338.

Clearance record

Decision date
Received
(36 days to decision)
Product code
CBT Arterial Blood Sampling Kit
Regulation
21 CFR 868.1100
Device class
Class I
Review panel
Anesthesiology
Applicant
Terumo Medical Corp. 125 Blue Ball Rd., Elkton MD
Third party review
No

Clearances, product code CBT

Trailing 12 months

FDA records hold no clearances under product code CBT in the trailing twelve months.

FDA records show no clearances under product code CBT in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code CBT, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260