Cleared Traditional

K811678 - GAMBRO WATER PURIFICATION MONITOR WRD

K811678 is an FDA 510(k) clearance for GAMBRO WATER PURIFICATION MONITOR WRD, manufactured by Gambro, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FIP cleared through the Traditional 510(k) pathway after a 25-day FDA review.

K811678 · Gambro, Inc. · Gastroenterology & Urology device
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Jul 1981
Decision
25d
Days
Class 2
Risk

K811678 is an FDA 510(k) clearance for the GAMBRO WATER PURIFICATION MONITOR WRD. Classified as Subsystem, Water Purification (product code FIP), Class II - Special Controls.

Submitted by Gambro, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 10, 1981 after a review of 25 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5665 - 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 - K811678

510(k) Number K811678 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 1981
Decision Date July 10, 1981
Days to Decision 25 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
105d faster than avg
Panel avg: 130d · This submission: 25d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FIP Device Classification - Class 2, Special Controls

Product Code FIP Subsystem, Water Purification
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5665
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 - FIP Subsystem, Water Purification

All 27
Devices cleared under the same product code (FIP) and FDA review panel - the closest regulatory comparables to K811678.
ASCORBIC ACID
K842215 · Organon Teknika Corp. · Aug 1984
HEMO-RO WATER PURIFICATION SYS
K841403 · Millipore Corp. · Jul 1984
EXTRAPURE REVERSE OSMOSIS WATER UNIT
K822385 · Extracorporeal Medical Specialities, Inc. · Oct 1982
CENTRY 2 SYSTEM #016, 103, 016, 104
K791086 · Cobe Laboratories, Inc. · Jul 1979
HEMO-RO
K771763 · Millipore Corp. · Oct 1977