Cleared Traditional

PREZA-PAK II, ARTERIAL BLOOD SAMPLING SY (K812338) - FDA 510(k) Clearance

Class I Anesthesiology device.

K812338 · Terumo Medical Corp. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1981
Decision
36d
Days
Class 1
Risk

K812338 is an FDA 510(k) clearance for the PREZA-PAK II, ARTERIAL BLOOD SAMPLING SY. Classified as Arterial Blood Sampling Kit (product code CBT), Class I - General Controls.

Submitted by Terumo Medical Corp. (Elkton, US). The FDA issued a Cleared decision on September 23, 1981 after a review of 36 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1100 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Terumo Medical Corp. devices

Submission Details

510(k) Number K812338 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 1981
Decision Date September 23, 1981
Days to Decision 36 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
104d faster than avg
Panel avg: 140d · This submission: 36d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CBT Arterial Blood Sampling Kit
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.1100
Definition 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 Guidance Above, Is Under Enforcement Discretion, And Does Not Require A Premarket Notification (510(k)) To Market If It Meets All Criteria In The Guidance.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - CBT Arterial Blood Sampling Kit

All 7
Devices cleared under the same product code (CBT) and FDA review panel - the closest regulatory comparables to K812338.
SHERWOOD MEDICAL ARTERIAL BLOOD GAS KIT II
K930471 · Sherwood Medical Co. · Jun 1993
UMBILICAL CORD BLOOD SAMPLING KIT
K900302 · Ge Medical Systems Information Technologies · Apr 1990
CIBA CORNING BALANCED HEPARIN FOR CA++
K875117 · Ciba Corning Diagnostics Corp. · Feb 1988
BARD-PARKER ARTERIAL MONITORING SYSTEM
K780939 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jul 1978