Cleared Traditional

WALKMED 300, WALKMED 350, WALKMED IC, WALKMED PCA, WALKMED PLUS (K991275) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

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 220
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, 6 THERAPY CONFIGURATION, 1 THERAPY CONFIGURATION
K000821 · Abbott Laboratories · Mar 2000
ABBOTT GEMSTAR I.V. INFUSION PUMP-7 THERAPY CONFIGURATION, ABBOTT GEMSTAR I.V. INFUSION PUMP-6 THERAPY CONFIGURATION, AB
K994039 · Abbott Laboratories · Dec 1999
IPUMP PAIN MANAGEMENT SYSTEM, MODEL 2L3107K
K993387 · Baxter Healthcare Corp · Nov 1999
ACCLAIM INFUSION PUMP
K991501 · Abbott Laboratories · May 1999
ABBOTT PLUM A+ INFUSION PUMP
K982159 · Abbott Laboratories · Jan 1999
ABBOTT LIFECARE STANDARD TUBING INFUSION PUMP
K983838 · Abbott Laboratories · Nov 1998