Cleared Traditional

MYELOGRAPHY TRAY W/CHYNN MYELOGRAPHY N (K760641) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K760641 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Cardiovascular device
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Oct 1976
Decision
24d
Days
Class 2
Risk

K760641 is an FDA 510(k) clearance for the MYELOGRAPHY TRAY W/CHYNN MYELOGRAPHY N. Classified as Injector, Contrast Medium, Automatic (product code IZQ), Class II - Special Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Washington, US). The FDA issued a Cleared decision on October 8, 1976 after a review of 24 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1650 - 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: 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 Bd Becton Dickinson Vacutainer Systems Preanalytic devices

Submission Details

510(k) Number K760641 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 1976
Decision Date October 08, 1976
Days to Decision 24 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
101d faster than avg
Panel avg: 125d · This submission: 24d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IZQ Injector, Contrast Medium, Automatic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1650
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 - IZQ Injector, Contrast Medium, Automatic

All 9
Devices cleared under the same product code (IZQ) and FDA review panel - the closest regulatory comparables to K760641.
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ulrichINJECT CT motion
K210541 · Ulrich GmbH & Co. KG · Aug 2021
ulrichINJECT CT Motion
K192872 · Ulrich GmbH & Co. KG · Jul 2020
MYELOGRAPHY TRAY W/CUATICO MYELOGRAP N
K760643 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1976