Cleared Traditional

K790574 - EPIC D215

K790574 is an FDA 510(k) clearance for EPIC D215, manufactured by National Patent Development Corp.. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K790574 · National Patent Development Corp. · General Hospital
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Apr 1979
Decision
38d
Days
Class 2
Risk

K790574 is an FDA 510(k) clearance for the EPIC D215. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by National Patent Development Corp. (Mchenry, US). The FDA issued a Cleared decision on April 30, 1979 after a review of 38 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5440 - the FDA general hospital 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: 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 National Patent Development Corp. devices

FDA 510(k) Submission Details - K790574

510(k) Number K790574 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 1979
Decision Date April 30, 1979
Days to Decision 38 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
91d faster than avg
Panel avg: 129d · This submission: 38d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FPA Device Classification - Class 2, Special Controls

Product Code FPA Set, Administration, Intravascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5440
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 General Hospital devices follow this clearance model.

Regulatory Peers - FPA Set, Administration, Intravascular

All 532
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K790574.
INTRAVASCULAR ADMINISTRATION SET
K790582 · Y · May 1979
CUSTOM TUBING SETS
K790604 · Norton Performance Plastics Corp. · May 1979
T-CONNECTOR
K790408 · Medex, Inc. · Apr 1979
IV ADMINISTRATION SET WITH BACKCHECK
K790062 · National Patent Development Corp. · Apr 1979
FILTERSET 0.22, I.V. PUMP
K790108 · Imed Corp. · Mar 1979
SOLUTION ADMINISTRATION, TIP PROTECTOR
K781813 · Travenol Laboratories, S.A. · Jan 1979