Cleared Traditional

INFUSION NEEDLE SET (K791529) - FDA 510(k) Clearance

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

K791529 · I.M.P. Group , Ltd. · General Hospital
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Oct 1979
Decision
53d
Days
Class 2
Risk

K791529 is an FDA 510(k) clearance for the INFUSION NEEDLE SET. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by I.M.P. Group , Ltd. (Mchenry, US). The FDA issued a Cleared decision on October 2, 1979 after a review of 53 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 I.M.P. Group , Ltd. devices

Submission Details

510(k) Number K791529 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 1979
Decision Date October 02, 1979
Days to Decision 53 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
76d faster than avg
Panel avg: 129d · This submission: 53d
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 K791529.
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