Cleared Traditional

K791529 - INFUSION NEEDLE SET

K791529 is an FDA 510(k) clearance for INFUSION NEEDLE SET, manufactured by I.M.P. Group , Ltd.. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 53-day FDA review.

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

FDA 510(k) Submission Details - K791529

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.

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 867
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K791529.
CONTINU-FLO ADMIN. SET CODE 2C/200
K792538 · Travenol Laboratories, S.A. · Dec 1979
ALBUMIN INTRAVENOUS ADMINISTRATION SET
K791672 · Delmed, Inc. · Oct 1979
IV EXTENSION SET SL
K791930 · Abbott Laboratories · Oct 1979
SURFLO INJECTION PLUG
K791173 · Terumo America, Inc. · Jul 1979
INTRAVASCULAR ADMINISTRATION SET
K790582 · Y · May 1979
CUSTOM TUBING SETS
K790604 · Norton Performance Plastics Corp. · May 1979