Cleared Traditional

K902853 - GRAVITY PLUS CONTROLLER/COMPOUNDER

K902853 is an FDA 510(k) clearance for GRAVITY PLUS CONTROLLER/COMPOUNDER, manufactured by Fergy Corp.. The device is a Class 2 General Hospital device with product code LHI cleared through the Traditional 510(k) pathway after a 314-day FDA review.

K902853 · Fergy Corp. · General Hospital
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May 1991
Decision
314d
Days
Class 2
Risk

K902853 is an FDA 510(k) clearance for the GRAVITY PLUS CONTROLLER/COMPOUNDER. Classified as Set, I.v. Fluid Transfer (product code LHI), Class II - Special Controls.

Submitted by Fergy Corp. (Grass Valley, US). The FDA issued a Cleared decision on May 9, 1991 after a review of 314 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5440 - 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. Elevated predicate reliance profile. 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 Fergy Corp. devices

FDA 510(k) Submission Details - K902853

510(k) Number K902853 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 29, 1990
Decision Date May 09, 1991
Days to Decision 314 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
185d slower than avg
Panel avg: 129d · This submission: 314d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LHI Device Classification - Class 2, Special Controls

Product Code LHI Set, I.v. Fluid Transfer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5440
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 - LHI Set, I.v. Fluid Transfer

All 153
Devices cleared under the same product code (LHI) and FDA review panel - the closest regulatory comparables to K902853.
IV FLUID TRANSFER PIN
K925401 · B. Braun of America, Inc. · Mar 1993
NUTRIMIX MICROCOMPOUNDER
K921365 · Abbott Laboratories · Jun 1992
ACACIAS PHARM/PUMP
K912771 · Acacia, Inc. · Feb 1992
NUTRIMIX(R) MACRO(TM) TPN COMPOUNDER/MODIFICATION
K910213 · Abbott Laboratories · Apr 1991
RECONSTITUTION DEVICE
K910793 · Baxter Healthcare Corp · Mar 1991
LUER LOCK TRANSFER PIN
K901063 · Acacia, Inc. · Jul 1990