Cleared Traditional

K820695 - AUTOMATIC DIALYZER REPROCESSOR #ADR-22

K820695 is an FDA 510(k) clearance for AUTOMATIC DIALYZER REPROCESSOR #ADR-22, manufactured by Texas Medical Devices, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code LIF cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K820695 · Texas Medical Devices, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1982
Decision
48d
Days
Class 2
Risk

K820695 is an FDA 510(k) clearance for the AUTOMATIC DIALYZER REPROCESSOR #ADR-22. Classified as Dialyzer Reprocessing System (product code LIF), Class II - Special Controls.

Submitted by Texas Medical Devices, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 29, 1982 after a review of 48 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 Texas Medical Devices, Inc. devices

FDA 510(k) Submission Details - K820695

510(k) Number K820695 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 1982
Decision Date April 29, 1982
Days to Decision 48 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
82d faster than avg
Panel avg: 130d · This submission: 48d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LIF Device Classification - Class 2, Special Controls

Product Code LIF Dialyzer Reprocessing System
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 - LIF Dialyzer Reprocessing System

All 17
Devices cleared under the same product code (LIF) and FDA review panel - the closest regulatory comparables to K820695.
HPR HOME PATIENT RENATRON
K833181 · Renal Systems, Inc. · Oct 1983
RENALIN (TENTATIVE
K830575 · Renal Systems, Inc. · Mar 1983
RENATRON DIALYZER REPROCESSING SYS
K830574 · Renal Systems, Inc. · Mar 1983
HYDROGEN PEROXIDE TOPICAL
K820221 · Renal Systems, Inc. · Mar 1982
MODEL RS 8300
K812230 · Renal Systems, Inc. · Nov 1981