Cleared Traditional

K864094 - GAMBRO FLUID CONTROL MONITOR FCM 10-1

K864094 is an FDA 510(k) clearance for GAMBRO FLUID CONTROL MONITOR FCM 10-1, manufactured by Gambro, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FKP cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K864094 · Gambro, Inc. · Gastroenterology & Urology device
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Nov 1986
Decision
17d
Days
Class 2
Risk

K864094 is an FDA 510(k) clearance for the GAMBRO FLUID CONTROL MONITOR FCM 10-1. Classified as System, Dialysate Delivery, Single Patient (product code FKP), Class II - Special Controls.

Submitted by Gambro, Inc. (Lincolnshire, US). The FDA issued a Cleared decision on November 7, 1986 after a review of 17 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5820 - the FDA gastroenterology and urology 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 Gambro, Inc. devices

FDA 510(k) Submission Details - K864094

510(k) Number K864094 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 1986
Decision Date November 07, 1986
Days to Decision 17 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
113d faster than avg
Panel avg: 130d · This submission: 17d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FKP Device Classification - Class 2, Special Controls

Product Code FKP System, Dialysate Delivery, Single Patient
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5820
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 Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - FKP System, Dialysate Delivery, Single Patient

All 36
Devices cleared under the same product code (FKP) and FDA review panel - the closest regulatory comparables to K864094.
HEOMDIALYSIS SINGLE PATIENT SYSTEM (SPS) MODEL 650
K883111 · Baxter Healthcare Corp · Feb 1989
GAMBRO BICART SYSTEM
K873155 · Gambro, Inc. · Oct 1987
MONITRAL S GS HEMODIALYSIS SINGLE PATIENT UNIT
K871218 · Hospal Medical Corp. · Apr 1987
GAMBRO BICARBONATE MONITOR BCM 10-2
K864083 · Gambro, Inc. · Nov 1986
MONITRAL S
K861230 · Hospal Medical Corp. · Apr 1986
HD-SECURA HEMADIALYSIS MACHINE
K854367 · Organon Teknika Corp. · Dec 1985