Cleared Traditional

K963574 - PULSE*SPRAY INJECTOR

K963574 is the FDA 510(k) clearance for PULSE*SPRAY INJECTOR by AngioDynamics, Inc.. It is a Class 2 General Hospital device (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

Submission Details

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.

Device Classification

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 433
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K963574.
SMITH & NEPHEW DYONICS INTELIJET REUSABLE CANNULAS
K980092 · Smith & Nephew, Inc. · Mar 1998
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY #M12/630
K973851 · Alexander Mfg. Co. · Jan 1998
IDA-4 AND IPT-MC
K973609 · Bio-Tek Instruments, Inc. · Dec 1997
MODELS IDA-2 PLUS AND IPT-1
K961862 · Bio-Tek Instruments, Inc. · Feb 1997
GEMINI PC-ITX
K960512 · Imed Corp. · Nov 1996
MEDFUSION MODEL 2001 SYRINGE INFUSION PUMP
K955231 · Medex, Inc. · Jul 1996