Cleared Traditional

K955663 - ABC IN-LINE BLOOD SAMPLING KIT

K955663 is an FDA 510(k) clearance for ABC IN-LINE BLOOD SAMPLING KIT, manufactured by Utah Medical Products, Inc.. The device is a Class 1 Anesthesiology device with product code CBT cleared through the Traditional 510(k) pathway after a 460-day FDA review.

K955663 · Utah Medical Products, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1997
Decision
460d
Days
Class 1
Risk

K955663 is an FDA 510(k) clearance for the ABC IN-LINE BLOOD SAMPLING KIT. Classified as Arterial Blood Sampling Kit (product code CBT), Class I - General Controls.

Submitted by Utah Medical Products, Inc. (Midvale, US). The FDA issued a Cleared decision on March 17, 1997 after a review of 460 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Anesthesiology submissions.

View all Utah Medical Products, Inc. devices

FDA 510(k) Submission Details - K955663

510(k) Number K955663 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 1995
Decision Date March 17, 1997
Days to Decision 460 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
320d slower than avg
Panel avg: 140d · This submission: 460d
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 K955663.
HEMODRAW ARTERIAL BLOOD SAMPLING SYSTEM
K071269 · Smiths Medical Asd, Inc. · Aug 2007
SECURE ARTERIAL BLOOD SAMPLING SYSTEM
K070340 · Smiths Medical Asd, Inc. · Mar 2007
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K954015 · Devon Industries, Inc. · Nov 1995
ASPIR-PULSE(TM) ARTERIAL BLOOD GAS (ABG) SYSTEM
K945719 · Sherwood Medical Co. · Mar 1995
ABG NEEDLE PROTECTION
K945485 · Devon Industries, Inc. · Nov 1994
ASPIR-PULSE(TM) SAF-T-VENT
K940575 · Sherwood Medical Co. · Mar 1994