Cleared Traditional

K840455 - EMERGENCY INFUSION DEVICE

K840455 is an FDA 510(k) clearance for EMERGENCY INFUSION DEVICE, manufactured by Arrow Intl., Inc.. The device is a Class 2 Cardiovascular device with product code DYB cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K840455 · Arrow Intl., Inc. · Cardiovascular device
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May 1984
Decision
111d
Days
Class 2
Risk

K840455 is an FDA 510(k) clearance for the EMERGENCY INFUSION DEVICE. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Arrow Intl., Inc. (Mchenry, US). The FDA issued a Cleared decision on May 23, 1984 after a review of 111 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1340 - the FDA cardiovascular device oversight 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 Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Arrow Intl., Inc. devices

FDA 510(k) Submission Details - K840455

510(k) Number K840455 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 1984
Decision Date May 23, 1984
Days to Decision 111 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
14d faster than avg
Panel avg: 125d · This submission: 111d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DYB Device Classification - Class 2, Special Controls

Product Code DYB Introducer, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1340
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DYB Introducer, Catheter

All 409
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K840455.
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