Cleared Traditional

K992266 - IV ADMINISTRATION SET

K992266 is an FDA 510(k) clearance for IV ADMINISTRATION SET, manufactured by New Alliance of Independent Medical Distributors,. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K992266 · New Alliance of Independent Medical Distributors, · General Hospital
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Oct 1999
Decision
113d
Days
Class 2
Risk

K992266 is an FDA 510(k) clearance for the IV ADMINISTRATION SET. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by New Alliance of Independent Medical Distributors, (Arcadia, US). The FDA issued a Cleared decision on October 27, 1999 after a review of 113 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 New Alliance of Independent Medical Distributors, devices

FDA 510(k) Submission Details - K992266

510(k) Number K992266 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 1999
Decision Date October 27, 1999
Days to Decision 113 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
16d faster than avg
Panel avg: 129d · This submission: 113d
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 772
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K992266.
DAISY PROTECTED SCALP VEIN SET
K992999 · Diasol, Inc. · Nov 1999
SHELLY PROTECTED AV FISTULA NEEDLE
K993187 · Diasol, Inc. · Nov 1999
DECAP
K993147 · The Kipp Group · Nov 1999
ECOMED SCALP VEIN SET
K992145 · Greiner Meditech, Inc. · Oct 1999
BOLUS ACCESSORY SET
K992072 · I-Flow Corp. · Sep 1999
NAC PRN NEEDLELESS ACCESS CONNECTOR
K992268 · The Kipp Group · Sep 1999