Cleared Traditional

K853270 - CENTERCOM CONTROL

K853270 is an FDA 510(k) clearance for CENTERCOM CONTROL, manufactured by Carrom Healthcare, Inc.. The device is a Class 2 General Hospital device with product code FNL cleared through the Traditional 510(k) pathway after a 100-day FDA review.

K853270 · Carrom Healthcare, Inc. · General Hospital
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Nov 1985
Decision
100d
Days
Class 2
Risk

K853270 is an FDA 510(k) clearance for the CENTERCOM CONTROL. Classified as Bed, Ac-powered Adjustable Hospital (product code FNL), Class II - Special Controls.

Submitted by Carrom Healthcare, Inc. (St. Louis, US). The FDA issued a Cleared decision on November 13, 1985 after a review of 100 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 Carrom Healthcare, Inc. devices

FDA 510(k) Submission Details - K853270

510(k) Number K853270 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 1985
Decision Date November 13, 1985
Days to Decision 100 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
29d faster than avg
Panel avg: 129d · This submission: 100d
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.

Regulatory Peers - FNL Bed, Ac-powered Adjustable Hospital

All 16
Devices cleared under the same product code (FNL) and FDA review panel - the closest regulatory comparables to K853270.
STRYKER 1990 LIBERTY ELECTRIC CRITICAL CARE BED
K875037 · Stryker Corp. · Feb 1988
HILL-ROM CENTURY CC, MODELS 891 & 893 WEIGHING SYS
K864172 · Hill-Rom, Inc. · Nov 1986
HILL-ROM CENTURY CC MODELS 892 &894 (RADIOLUCENT)
K864186 · Hill-Rom, Inc. · Nov 1986
STRYKER 988 ICU BED
K852674 · Stryker Corp. · Jul 1985
KINAIR, LOW AIR LOSS BED
K843781 · Kinetic Concepts, Inc. · Jan 1985