Cleared Traditional

K897133 - MODEL 1050 - UMBILICAL CORD BLOOD SAMPLING KIT (FDA 510(k) Clearance)

Class I Anesthesiology device.

K897133 · Transidyne General Corp. · Anesthesiology device
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Mar 1990
Decision
93d
Days
Class 1
Risk

K897133 is an FDA 510(k) clearance for the MODEL 1050 - UMBILICAL CORD BLOOD SAMPLING KIT. Classified as Arterial Blood Sampling Kit (product code CBT), Class I - General Controls.

Submitted by Transidyne General Corp. (Ann Arbor, US). The FDA issued a Cleared decision on March 30, 1990 after a review of 93 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 Transidyne General Corp. devices

Submission Details

510(k) Number K897133 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 1989
Decision Date March 30, 1990
Days to Decision 93 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
46d faster than avg
Panel avg: 139d · This submission: 93d
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.