Cleared Traditional

K822385 - EXTRAPURE REVERSE OSMOSIS WATER UNIT

K822385 is the FDA 510(k) clearance for EXTRAPURE REVERSE OSMOSIS WATER UNIT by Extracorporeal Medical Specialities, Inc.. It is a Class 2 Gastroenterology & Urology device (product code FIP) cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K822385 · Extracorporeal Medical Specialities, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1982
Decision
65d
Days
Class 2
Risk

K822385 is an FDA 510(k) clearance for the EXTRAPURE REVERSE OSMOSIS WATER UNIT. Classified as Subsystem, Water Purification (product code FIP), Class II - Special Controls.

Submitted by Extracorporeal Medical Specialities, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 13, 1982 after a review of 65 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 Extracorporeal Medical Specialities, Inc. devices

Submission Details

510(k) Number K822385 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 1982
Decision Date October 13, 1982
Days to Decision 65 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
65d faster than avg
Panel avg: 130d · This submission: 65d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 17
Devices cleared under the same product code (FIP) and FDA review panel - the closest regulatory comparables to K822385.
DIASAFEplusUS
K182367 · Fresenius Medical Care Renal Therapies Group, LLC · Jan 2019
EON Portable Reverse Osmosis Water Purification System
K171099 · Cantel · Jan 2018
ASCORBIC ACID
K842215 · Organon Teknika Corp. · Aug 1984
GAMBRO WATER PURIFICATION MONITOR WRD
K811678 · Gambro, Inc. · Jul 1981
CENTRY 2 SYSTEM #016, 103, 016, 104
K791086 · Cobe Laboratories, Inc. · Jul 1979