Cleared Traditional

K950059 - MC INFANT CARE UNIE #PP30

K950059 is an FDA 510(k) clearance for MC INFANT CARE UNIE #PP30, manufactured by Janco Consulting Services. The device is a Class 2 General Hospital device with product code FMS cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K950059 · Janco Consulting Services · General Hospital
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Feb 1995
Decision
35d
Days
Class 2
Risk

K950059 is an FDA 510(k) clearance for the MC INFANT CARE UNIE #PP30. Classified as Bed, Pediatric Open Hospital (product code FMS), Class II - Special Controls.

Submitted by Janco Consulting Services (L5n 1n7, CA). The FDA issued a Cleared decision on February 10, 1995 after a review of 35 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5140 - 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 Janco Consulting Services devices

FDA 510(k) Submission Details - K950059

510(k) Number K950059 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 06, 1995
Decision Date February 10, 1995
Days to Decision 35 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
94d faster than avg
Panel avg: 129d · This submission: 35d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FMS Device Classification - Class 2, Special Controls

Product Code FMS Bed, Pediatric Open Hospital
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5140
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.