Cleared Traditional

K821401 - MALLINCKRODT DIAG. MEDIA WARMER

K821401 is an FDA 510(k) clearance for MALLINCKRODT DIAG. MEDIA WARMER, manufactured by Forma Scientific, Inc.. The device is a Class 2 Cardiovascular device with product code DXT cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K821401 · Forma Scientific, Inc. · Cardiovascular device
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Jun 1982
Decision
37d
Days
Class 2
Risk

K821401 is an FDA 510(k) clearance for the MALLINCKRODT DIAG. MEDIA WARMER. Classified as Injector And Syringe, Angiographic (product code DXT), Class II - Special Controls.

Submitted by Forma Scientific, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 17, 1982 after a review of 37 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 Forma Scientific, Inc. devices

FDA 510(k) Submission Details - K821401

510(k) Number K821401 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 1982
Decision Date June 17, 1982
Days to Decision 37 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
88d faster than avg
Panel avg: 125d · This submission: 37d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXT Device Classification - Class 2, Special Controls

Product Code DXT Injector And Syringe, Angiographic
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 - DXT Injector And Syringe, Angiographic

All 172
Devices cleared under the same product code (DXT) and FDA review panel - the closest regulatory comparables to K821401.
ULTRA-ASEPT ANGIOGRAPHIC SYRINGE/SPARE
K823256 · Vertex Medical Corp. · Dec 1982
CLEAR VINYL MONITORING CONNECTOR
K823340 · Vertex Medical Corp. · Dec 1982
MARK V
K822536 · Medrad, Inc. · Sep 1982
QUICK FILL
K800823 · Medrad, Inc. · Apr 1980
ANGIOPLASTY INJECTOR
K800613 · Medrad, Inc. · Apr 1980
USCI BALLOON DILATATION INFLATION DEV.
K791782 · C.R. Bard, Inc. · Dec 1979