Cleared Traditional

K844615 - BIOSAMPLER

K844615 is an FDA 510(k) clearance for BIOSAMPLER, manufactured by Biotek-Caribbean. The device is a Class 1 Anesthesiology device with product code CBT cleared through the Traditional 510(k) pathway after a 114-day FDA review.

K844615 · Biotek-Caribbean · Anesthesiology device
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Mar 1985
Decision
114d
Days
Class 1
Risk

K844615 is an FDA 510(k) clearance for the BIOSAMPLER. Classified as Arterial Blood Sampling Kit (product code CBT), Class I - General Controls.

Submitted by Biotek-Caribbean (Santo Domingo, Dom. Rep., DO). The FDA issued a Cleared decision on March 21, 1985 after a review of 114 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Biotek-Caribbean devices

FDA 510(k) Submission Details - K844615

510(k) Number K844615 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 27, 1984
Decision Date March 21, 1985
Days to Decision 114 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
26d faster than avg
Panel avg: 140d · This submission: 114d
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 40
Devices cleared under the same product code (CBT) and FDA review panel - the closest regulatory comparables to K844615.
MODEL 1050 - UMBILICAL CORD BLOOD SAMPLING KIT
K897133 · Transidyne General Corp. · Mar 1990
CIBA CORNING BALANCED HEPARIN FOR CA++
K875117 · Ciba Corning Diagnostics Corp. · Feb 1988
AIRLIFE ARTERIAL BLOOD GAS SAMPLING SYRINGE
K870720 · American Pharmaseal Div. Ahsc · Mar 1987
ARTAP ARTERIAL BLOOD SAMPLING DEVICE
K843360 · Analytical Products, Inc. · Oct 1984
MARQUEST MICRO STIK 9000 SERIES
K842008 · Marquest Medical Products, Inc. · May 1984
ARTERIAL BLOOD SAMPLING KITS
K841486 · Concord Laboratories, Inc. · May 1984