Cleared Traditional

K881961 - MSI STANDARD BED MODELS: L1097-64 AND L1085-64

K881961 is an FDA 510(k) clearance for MSI STANDARD BED MODELS: L1097-64 AND L..., manufactured by Med Service, Inc.. The device is a Class 1 General Hospital device with product code FNJ cleared through the Traditional 510(k) pathway after a 175-day FDA review.

K881961 · Med Service, Inc. · General Hospital
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Nov 1988
Decision
175d
Days
Class 1
Risk

K881961 is an FDA 510(k) clearance for the MSI STANDARD BED MODELS: L1097-64 AND L1085-64. Classified as Bed, Manual (product code FNJ), Class I - General Controls.

Submitted by Med Service, Inc. (Batesville, US). The FDA issued a Cleared decision on November 1, 1988 after a review of 175 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5120 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Med Service, Inc. devices

FDA 510(k) Submission Details - K881961

510(k) Number K881961 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 1988
Decision Date November 01, 1988
Days to Decision 175 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
46d slower than avg
Panel avg: 129d · This submission: 175d
Pathway characteristics
Predicate-based equivalence.

FNJ Device Classification - Class 1, General Controls

Product Code FNJ Bed, Manual
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.5120
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 - FNJ Bed, Manual

All 9
Devices cleared under the same product code (FNJ) and FDA review panel - the closest regulatory comparables to K881961.
CRADLE, HOSPITAL BED CLOTHING
K892877 · Warsaw Orthopedic, Inc. · Jun 1989
ICU/CPU TRANSPORT TRAY
K864878 · Orthopedic Systems, Inc. · Jan 1987
EGERTON TURNING & TILTING NET SUSPEN BED
K832845 · Kinetic Concepts, Inc. · Nov 1983
SIDE RAIL PADS
K823821 · Danek Medical, Inc. · Jan 1983
SKIL-CARE BED RAIL PADS
K791993 · Skil-Care Corp. · Oct 1979
TELESCOPING BEDRAILS
K772260 · Med Fusion Systems, Inc. · Jan 1978