Cleared Traditional

S & W SW52E W/POWER BACK LIFT (K832768) - FDA 510(k) Clearance

Class I General Hospital device.

K832768 · S & W Enterprises, Inc. · General Hospital
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Sep 1983
Decision
35d
Days
Class 1
Risk

K832768 is an FDA 510(k) clearance for the S & W SW52E W/POWER BACK LIFT. Classified as Table, Examination, Medical, Powered (product code LGX), Class I - General Controls.

Submitted by S & W Enterprises, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 20, 1983 after a review of 35 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4960 - 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 S & W Enterprises, Inc. devices

Submission Details

510(k) Number K832768 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 1983
Decision Date September 20, 1983
Days to Decision 35 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
94d faster than avg
Panel avg: 129d · This submission: 35d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LGX Table, Examination, Medical, Powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4960
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.