Cleared Traditional

K963574 - PULSE*SPRAY INJECTOR

K963574 is an FDA 510(k) clearance for PULSE*SPRAY INJECTOR, manufactured by AngioDynamics, Inc.. The device is a Class 2 General Hospital device with product code FRN cleared through the Traditional 510(k) pathway after a 315-day FDA review.

K963574 · AngioDynamics, Inc. · General Hospital
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Jul 1997
Decision
315d
Days
Class 2
Risk

K963574 is an FDA 510(k) clearance for the PULSE*SPRAY INJECTOR. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by AngioDynamics, Inc. (Queensburgy, US). The FDA issued a Cleared decision on July 18, 1997 after a review of 315 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5725 - 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. Elevated predicate reliance profile. 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 AngioDynamics, Inc. devices

FDA 510(k) Submission Details - K963574

510(k) Number K963574 FDA.gov
FDA Decision Cleared Substantially Equivalent - Third Party Review (ST)
Date Received September 06, 1996
Decision Date July 18, 1997
Days to Decision 315 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
186d slower than avg
Panel avg: 129d · This submission: 315d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FRN Device Classification - Class 2, Special Controls

Product Code FRN Pump, Infusion
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5725
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 - FRN Pump, Infusion

All 582
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K963574.
FLUID MANAGEMENT SYSTEM
K972284 · Belmont Instrument Corp. · Nov 1997
MILLENNIUM CRT INFUSION PUMP AND MILLENNIUM CRT INFUSION PUMP ADMINISTRATION SETS
K972678 · Mcgaw, Inc. · Oct 1997
BIG BAG 3000 PRESSURE INFUSOR
K973133 · Byron Medical · Sep 1997
ABBOTT LIFECARE STANDARD TUBING INFUSION PUMP
K965230 · Abbott Mfg., Inc. · Jul 1997
MODELS IDA-2 PLUS AND IPT-1
K961862 · Bio-Tek Instruments, Inc. · Feb 1997
DISETRONIC D-MODEM
K961975 · Disetronic Medical Systems · Jan 1997