Cleared Traditional

K864327 - MODEL 304-S EXTERNAL MICRO-VOLUME INFUSION PUMP

K864327 is an FDA 510(k) clearance for MODEL 304-S EXTERNAL MICRO-VOLUME INFUS..., manufactured by Medtronic Minimed. The device is a Class 1 General Hospital device with product code FRW cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K864327 · Medtronic Minimed · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1987
Decision
94d
Days
Class 1
Risk

K864327 is an FDA 510(k) clearance for the MODEL 304-S EXTERNAL MICRO-VOLUME INFUSION PUMP. Classified as Scale, Patient (product code FRW), Class I - General Controls.

Submitted by Medtronic Minimed (Sylmar, US). The FDA issued a Cleared decision on February 6, 1987 after a review of 94 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.2720 - 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 Medtronic Minimed devices

FDA 510(k) Submission Details - K864327

510(k) Number K864327 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 1986
Decision Date February 06, 1987
Days to Decision 94 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
35d faster than avg
Panel avg: 129d · This submission: 94d
Pathway characteristics
Predicate-based equivalence.

FRW Device Classification - Class 1, General Controls

Product Code FRW Scale, Patient
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.2720
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - FRW Scale, Patient

All 14
Devices cleared under the same product code (FRW) and FDA review panel - the closest regulatory comparables to K864327.
OLYMPIC SMART SCALE PEDIATRICS MODEL 50
K901522 · Olympic Medical Corp. · Jun 1990
OLYMPIC SMART SCALE
K871104 · Olympic Medical Corp. · May 1987
WARM WEIGH MODEL N-10 INFANT SCALE
K870888 · Air-Shields, Inc. · Mar 1987
MODEL AS* 6C INFUSION PUMP
K791566 · Baxter Healthcare Corp · Nov 1979
WEIGHING STATION, MOBILE PATIENT
K760545 · Gaymar Industries, Inc. · Nov 1976