Cleared Traditional

K872876 - IMSI/EASY FLOAT MATTRESS (FDA 510(k) Clearance)

Class I General Hospital device.

K872876 · Intl. Management Services, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1987
Decision
84d
Days
Class 1
Risk

K872876 is an FDA 510(k) clearance for the IMSI/EASY FLOAT MATTRESS. Classified as Mattress, Water, Temperature Regulated (product code FOH), Class I - General Controls.

Submitted by Intl. Management Services, Inc. (Lincoln, US). The FDA issued a Cleared decision on October 13, 1987 after a review of 84 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5560 - 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 Intl. Management Services, Inc. devices

Submission Details

510(k) Number K872876 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 1987
Decision Date October 13, 1987
Days to Decision 84 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 128d · This submission: 84d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FOH Mattress, Water, Temperature Regulated
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.5560
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.