Cleared Traditional

K922670 - THE MINIMED MODEL 404-SP AND 504-S

K922670 is the FDA 510(k) clearance for THE MINIMED MODEL 404-SP AND 504-S by Medtronic Minimed. It is a Class 2 General Hospital device (product code FRN) cleared through the Traditional 510(k) pathway after a 521-day FDA review.

K922670 · Medtronic Minimed · General Hospital
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Sep 1993
Decision
521d
Days
Class 2
Risk

K922670 is an FDA 510(k) clearance for the THE MINIMED MODEL 404-SP AND 504-S. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Medtronic Minimed (Sylmar, US). The FDA issued a Cleared decision on September 16, 1993 after a review of 521 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Medtronic Minimed devices

Submission Details

510(k) Number K922670 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 1992
Decision Date September 16, 1993
Days to Decision 521 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
392d slower than avg
Panel avg: 129d · This submission: 521d
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
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