Cleared Traditional

K905122 - SENTRY SCALE

K905122 is an FDA 510(k) clearance for SENTRY SCALE, manufactured by Apollo Enterprise, Ltd. Co.. The device is a Class 1 General Hospital device with product code FRW cleared through the Traditional 510(k) pathway after a 121-day FDA review.

K905122 · Apollo Enterprise, Ltd. Co. · General Hospital
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Mar 1991
Decision
121d
Days
Class 1
Risk

K905122 is an FDA 510(k) clearance for the SENTRY SCALE. Classified as Scale, Patient (product code FRW), Class I - General Controls.

Submitted by Apollo Enterprise, Ltd. Co. (Somerset, US). The FDA issued a Cleared decision on March 15, 1991 after a review of 121 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.2720 - 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 Apollo Enterprise, Ltd. Co. devices

FDA 510(k) Submission Details - K905122

510(k) Number K905122 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 1990
Decision Date March 15, 1991
Days to Decision 121 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
8d faster than avg
Panel avg: 129d · This submission: 121d
Pathway characteristics
Predicate-based equivalence.

FRW Device Classification - Class 1, General Controls

Product Code FRW Scale, Patient
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.2720
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.

Regulatory Peers - FRW Scale, Patient

All 15
Devices cleared under the same product code (FRW) and FDA review panel - the closest regulatory comparables to K905122.
3M MODEL 280RT RATE TAPER INFUSION PUMP
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3M MODEL 200RT RATE TAPER INFUSION PUMP
K926059 · 3M Health Care, Ltd. · Aug 1993
DISETRONIC DOLOMAT PUMP
K920063 · Disetronic Medical Systems · Aug 1993
SMART SCALE X-RAY PLATFORM
K904138 · Olympic Medical Corp. · Nov 1990
VAAKA BABY SCALE
K902545 · Ferguson Medical · Jul 1990
OLYMPIC SMART SCALE PEDIATRICS MODEL 50
K901522 · Olympic Medical Corp. · Jun 1990