Cleared Traditional

MANGAR BOOSTER (K905414) - FDA 510(k) Clearance

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

K905414 · Northfleet Management Group, Inc. · General Hospital
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Mar 1991
Decision
92d
Days
Class 2
Risk

K905414 is an FDA 510(k) clearance for the MANGAR BOOSTER. Classified as Lift, Patient, Ac-powered (product code FNG), Class II - Special Controls.

Submitted by Northfleet Management Group, Inc. (Hopkinton, US). The FDA issued a Cleared decision on March 5, 1991 after a review of 92 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5500 - 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 Northfleet Management Group, Inc. devices

Submission Details

510(k) Number K905414 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 1990
Decision Date March 05, 1991
Days to Decision 92 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
37d faster than avg
Panel avg: 129d · This submission: 92d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FNG Lift, Patient, Ac-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5500
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.