Cleared Traditional

K991275 - WALKMED 300, WALKMED 350, WALKMED IC, WALKMED PCA, WALKMED PLUS

K991275 is an FDA 510(k) clearance for WALKMED 300, manufactured by Mckinley, Inc.. The device is a Class 2 General Hospital device with product code FRN cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K991275 · Mckinley, Inc. · General Hospital
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Jul 1999
Decision
78d
Days
Class 2
Risk

K991275 is an FDA 510(k) clearance for the WALKMED 300, WALKMED 350, WALKMED IC, WALKMED PCA, WALKMED PLUS. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Mckinley, Inc. (Wheat Ridge, US). The FDA issued a Cleared decision on July 1, 1999 after a review of 78 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Mckinley, Inc. devices

FDA 510(k) Submission Details - K991275

510(k) Number K991275 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 1999
Decision Date July 01, 1999
Days to Decision 78 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
51d faster than avg
Panel avg: 129d · This submission: 78d
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 535
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K991275.
ABBOTT GEMSTAR I.V. INFUSION PUMP-7 THERAPY CONFIGURATION, ABBOTT GEMSTAR I.V. INFUSION PUMP-6 THERAPY CONFIGURATION, AB
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ACCLAIM INFUSION PUMP
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