Cleared Traditional

MSI STANDARD BED MODELS L1098-84/L1098-74/L1085-74 (K881960) - FDA 510(k) Clearance

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

K881960 · Med Service, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1988
Decision
175d
Days
Class 2
Risk

K881960 is an FDA 510(k) clearance for the MSI STANDARD BED MODELS L1098-84/L1098-74/L1085-74. Classified as Bed, Ac-powered Adjustable Hospital (product code FNL), Class II - Special 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 880.5100 - 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

Submission Details

510(k) Number K881960 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. No clinical trials required.

Device Classification

Product Code FNL Bed, Ac-powered Adjustable Hospital
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5100
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 - FNL Bed, Ac-powered Adjustable Hospital

Devices cleared under the same product code (FNL) and FDA review panel - the closest regulatory comparables to K881960.
iBed Wireless with iBed Mobile
K202964 · Stryker Corporation · Jun 2021
MEDLINE A/C POWERED HEALTHCARE BEDS & ACCESSORIES
K932663 · Medline Industries, Inc. · Nov 1993
STRYKER MPS ACUTE CARE BED
K931482 · Stryker Corp. · Sep 1993
STRYKER 1990 LIBERTY ELECTRIC CRITICAL CARE BED
K875037 · Stryker Corp. · Feb 1988
STRYKER 988 ICU BED
K852674 · Stryker Corp. · Jul 1985