Cleared Traditional

K950419 - THE IMED ORION INFUSION PUMP AND ADMINISTRATION SETS

K950419 is an FDA 510(k) clearance for THE IMED ORION INFUSION PUMP AND ADMINI..., manufactured by Imed Corp.. The device is a Class 2 General Hospital device with product code FRN cleared through the Traditional 510(k) pathway after a 141-day FDA review.

K950419 · Imed Corp. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1995
Decision
141d
Days
Class 2
Risk

K950419 is an FDA 510(k) clearance for the THE IMED ORION INFUSION PUMP AND ADMINISTRATION SETS. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Imed Corp. (San Diego, US). The FDA issued a Cleared decision on June 21, 1995 after a review of 141 days - within the typical 510(k) review window.

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 Imed Corp. devices

FDA 510(k) Submission Details - K950419

510(k) Number K950419 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 1995
Decision Date June 21, 1995
Days to Decision 141 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
12d slower than avg
Panel avg: 129d · This submission: 141d
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 526
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K950419.
DISETRONIC D-MODEM
K943952 · Disetronic Medical Systems · Oct 1995
ADI SYSTEM
K933825 · Abbott Laboratories · Sep 1995
AUTO SYRINGE(R) AS50 INFUSION PUMP
K945942 · Baxter Healthcare Corp · Jul 1995
LIFECARE 175 INFUSER, MODIFICATION
K944190 · Abbott Laboratories · May 1995
SMART DOSE(TM)
K943692 · River Medical, Inc. · Apr 1995
PLUM XL INFUSION PUMP
K944733 · Abbott Laboratories · Feb 1995