Cleared Traditional

K820875 - AUTOSTIK

K820875 is an FDA 510(k) clearance for AUTOSTIK, manufactured by Marquest Medical Products, Inc.. The device is a Class 1 Anesthesiology device with product code CBT cleared through the Traditional 510(k) pathway after a 39-day FDA review.

K820875 · Marquest Medical Products, Inc. · Anesthesiology device
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May 1982
Decision
39d
Days
Class 1
Risk

K820875 is an FDA 510(k) clearance for the AUTOSTIK. Classified as Arterial Blood Sampling Kit (product code CBT), Class I - General Controls.

Submitted by Marquest Medical Products, Inc. (Englewood, US). The FDA issued a Cleared decision on May 7, 1982 after a review of 39 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 Marquest Medical Products, Inc. devices

FDA 510(k) Submission Details - K820875

510(k) Number K820875 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 1982
Decision Date May 07, 1982
Days to Decision 39 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
101d faster than avg
Panel avg: 140d · This submission: 39d
Pathway characteristics
Predicate-based equivalence.

CBT Device Classification - Class 1, General Controls

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 34
Devices cleared under the same product code (CBT) and FDA review panel - the closest regulatory comparables to K820875.
QUALISTICK ARTERIAL BLOOD SAMPLER
K831034 · Radiometer America, Inc. · May 1983
DESERET ARTERIAL BLOOD SAMPLING KIT
K822248 · Warner-Lambert Co. · Oct 1982
ARTERIAL BLOOD SAMPLING KIT
K821406 · Dhd Medical Products Div. Diemolding Corp. · Jun 1982
PREZA-PAK II, ARTERIAL BLOOD SAMPLING SY
K812338 · Terumo Medical Corp. · Sep 1981
EASY-FLO ARTERIAL BLOOD GAS KIT
K811860 · Dhd Medical Products Div. Diemolding Corp. · Jul 1981
ASPIRATOR
K801620 · Marquest Medical Products, Inc. · Jul 1980