Cleared Traditional

K914988 - 500 INFUSER

K914988 is an FDA 510(k) clearance for 500 INFUSER, manufactured by Excel Medical, Inc.. The device is a Class 2 General Hospital device with product code FRN cleared through the Traditional 510(k) pathway after a 152-day FDA review.

K914988 · Excel Medical, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1992
Decision
152d
Days
Class 2
Risk

K914988 is an FDA 510(k) clearance for the 500 INFUSER. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Excel Medical, Inc. (Asbury Park, US). The FDA issued a Cleared decision on April 6, 1992 after a review of 152 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 Excel Medical, Inc. devices

FDA 510(k) Submission Details - K914988

510(k) Number K914988 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 1991
Decision Date April 06, 1992
Days to Decision 152 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
23d slower than avg
Panel avg: 129d · This submission: 152d
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 613
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K914988.
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K920680 · 3M Health Care, Ltd. · Apr 1992
AVI MODEL 285CI INFUSION PUMP
K920681 · 3M Health Care, Ltd. · Apr 1992