Cleared Traditional

IV ADMINISTRATION SET WITH BACKCHECK (K790062) - FDA 510(k) Clearance

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

K790062 · National Patent Development Corp. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1979
Decision
90d
Days
Class 2
Risk

K790062 is an FDA 510(k) clearance for the IV ADMINISTRATION SET WITH BACKCHECK. 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 10, 1979 after a review of 90 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all National Patent Development Corp. devices

Submission Details

510(k) Number K790062 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 10, 1979
Decision Date April 10, 1979
Days to Decision 90 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 129d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 238
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K790062.
VENTED I.V. SET
K792228 · Abbott Laboratories · Jan 1980
CONTINU-FLO ADMIN. SET CODE 2C/200
K792538 · Travenol Laboratories, S.A. · Dec 1979
IV EXTENSION SET SL
K791930 · Abbott Laboratories · Oct 1979
SOLUTION ADMINISTRATION, TIP PROTECTOR
K781813 · Travenol Laboratories, S.A. · Jan 1979
FILTER FOR HYPERALIMENTATION SET
K782134 · Travenol Laboratories, S.A. · Jan 1979
SOLUTION ADMINISTRATION, FLEX VALVE
K781812 · Travenol Laboratories, S.A. · Dec 1978