Cleared Traditional

K893488 - PULSATILE PUMP FOR GONADORELIN ACETATE

K893488 is the FDA 510(k) clearance for PULSATILE PUMP FOR GONADORELIN ACETATE by Ortho Pharmaceutical Corp.. It is a Class 2 General Hospital device (product code FRN) cleared through the Traditional 510(k) pathway after a 180-day FDA review.

K893488 · Ortho Pharmaceutical Corp. · General Hospital
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Oct 1989
Decision
180d
Days
Class 2
Risk

K893488 is an FDA 510(k) clearance for the PULSATILE PUMP FOR GONADORELIN ACETATE. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Ortho Pharmaceutical Corp. (Raritan, US). The FDA issued a Cleared decision on October 31, 1989 after a review of 180 days - an extended review cycle.

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. 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 Ortho Pharmaceutical Corp. devices

Submission Details

510(k) Number K893488 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 1989
Decision Date October 31, 1989
Days to Decision 180 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
51d slower than avg
Panel avg: 129d · This submission: 180d
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 444
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K893488.
BECTON DICKINSON RATE INFUSER II SYSTEM
K896593 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1989
MODEL 600 SYRINGE PUMP
K891237 · 3M Company · Dec 1989
BARD LIBERATOR DISPOSABLE INFUSION SYSTEM
K894292 · C.R. Bard, Inc. · Nov 1989
MODEL 285 INFUSION PUMP
K894321 · 3M Company · Oct 1989
MODEL 480 INFUSION PUMP
K894320 · 3M Company · Oct 1989
MODEL 280 INFUSION PUMP
K894360 · 3M Company · Oct 1989