Cleared Traditional

K821185 - NEW SUPPORT SYS. FOR BEDRIDDEN PATIENTS

K821185 is an FDA 510(k) clearance for NEW SUPPORT SYS. FOR BEDRIDDEN PATIENTS, manufactured by Dase Co.. The device is a Class 2 General Hospital device with product code FNL cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K821185 · Dase Co. · General Hospital
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Sep 1982
Decision
140d
Days
Class 2
Risk

K821185 is an FDA 510(k) clearance for the NEW SUPPORT SYS. FOR BEDRIDDEN PATIENTS. Classified as Bed, Ac-powered Adjustable Hospital (product code FNL), Class II - Special Controls.

Submitted by Dase Co. (Mchenry, US). The FDA issued a Cleared decision on September 14, 1982 after a review of 140 days - within the typical 510(k) review window.

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 Dase Co. devices

FDA 510(k) Submission Details - K821185

510(k) Number K821185 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 1982
Decision Date September 14, 1982
Days to Decision 140 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
11d slower than avg
Panel avg: 129d · This submission: 140d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FNL Device Classification - Class 2, Special Controls

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.