Cleared Traditional

K902446 - DISPOSABLE STERILE TABLE TOP COVER FOR HYDRADJUST

K902446 is an FDA 510(k) clearance for DISPOSABLE STERILE TABLE TOP COVER FOR ..., manufactured by Mallinckrodt Group, Inc.. The device is a Class 1 General Hospital device with product code FMW cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K902446 · Mallinckrodt Group, Inc. · General Hospital
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Aug 1990
Decision
70d
Days
Class 1
Risk

K902446 is an FDA 510(k) clearance for the DISPOSABLE STERILE TABLE TOP COVER FOR HYDRADJUST. Classified as Cover, Mattress (medical Purposes) (product code FMW), Class I - General Controls.

Submitted by Mallinckrodt Group, Inc. (Cincinnati, US). The FDA issued a Cleared decision on August 10, 1990 after a review of 70 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6190 - 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 Mallinckrodt Group, Inc. devices

FDA 510(k) Submission Details - K902446

510(k) Number K902446 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 1990
Decision Date August 10, 1990
Days to Decision 70 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 129d · This submission: 70d
Pathway characteristics
Predicate-based equivalence.

FMW Device Classification - Class 1, General Controls

Product Code FMW Cover, Mattress (medical Purposes)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6190
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.

Regulatory Peers - FMW Cover, Mattress (medical Purposes)

Devices cleared under the same product code (FMW) and FDA review panel - the closest regulatory comparables to K902446.
DERMATHERAPY, MODEL 22216
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EVENT ALLERGEN BARRIERS, EVENT MATTRESS ENCASING, EVENT DUVET ENCASING, EVENT PILLOW ENCASING, EVENT BEDDING SYSTEM
K992702 · Allergy Direct · Nov 1999
INTERVENT ALLERGEN EXCLUSION TECHNOLOGY, INTERVENT BEDDING SYSTEM, INTERVENT MATTRESS INTERLINER, INTERVIEW PILLOW
K940327 · W.L. Gore & Associates, Inc. · Feb 1994
MATTRESS COVER, ANTI-MICROBIAL
K832483 · American Threshold Industries, Inc. · Feb 1984