Cleared Traditional

K875117 - CIBA CORNING BALANCED HEPARIN FOR CA++

K875117 is an FDA 510(k) clearance for CIBA CORNING BALANCED HEPARIN FOR CA++, manufactured by Ciba Corning Diagnostics Corp.. The device is a Class 1 Anesthesiology device with product code CBT cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K875117 · Ciba Corning Diagnostics Corp. · Anesthesiology device
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Feb 1988
Decision
76d
Days
Class 1
Risk

K875117 is an FDA 510(k) clearance for the CIBA CORNING BALANCED HEPARIN FOR CA++. Classified as Arterial Blood Sampling Kit (product code CBT), Class I - General Controls.

Submitted by Ciba Corning Diagnostics Corp. (East Walpole, US). The FDA issued a Cleared decision on February 29, 1988 after a review of 76 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 Ciba Corning Diagnostics Corp. devices

FDA 510(k) Submission Details - K875117

510(k) Number K875117 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 1987
Decision Date February 29, 1988
Days to Decision 76 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
64d faster than avg
Panel avg: 140d · This submission: 76d
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 36
Devices cleared under the same product code (CBT) and FDA review panel - the closest regulatory comparables to K875117.
SHERWOOD MEDICAL ARTERIAL BLOOD GAS KIT II
K930471 · Sherwood Medical Co. · Jun 1993
GAS-LYTE 1CC AND 3CC ARTERIAL BLOOD SAMPLERS
K902632 · Marquest Medical Products, Inc. · Sep 1990
UMBILICAL CORD BLOOD SAMPLING KIT
K900302 · Ge Medical Systems Information Technologies · Apr 1990
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