Cleared Traditional

K962942 - TOTALCARE

K962942 is the FDA 510(k) clearance for TOTALCARE by Hill-Rom, Inc.. It is a Class 2 General Hospital device (product code FNL) cleared through the Traditional 510(k) pathway after a 189-day FDA review.

K962942 · Hill-Rom, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1997
Decision
189d
Days
Class 2
Risk

K962942 is an FDA 510(k) clearance for the TOTALCARE. Classified as Bed, Ac-powered Adjustable Hospital (product code FNL), Class II - Special Controls.

Submitted by Hill-Rom, Inc. (Batesville, US). The FDA issued a Cleared decision on February 3, 1997 after a review of 189 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 Hill-Rom, Inc. devices

Submission Details

510(k) Number K962942 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 1996
Decision Date February 03, 1997
Days to Decision 189 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
60d slower than avg
Panel avg: 129d · This submission: 189d
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

All 11
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