Cleared Traditional

K853817 - COBE REN NEW-D DISPENSING KIT

K853817 is an FDA 510(k) clearance for COBE REN NEW-D DISPENSING KIT, manufactured by Cobe Laboratories, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code LIF cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K853817 · Cobe Laboratories, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1985
Decision
35d
Days
Class 2
Risk

K853817 is an FDA 510(k) clearance for the COBE REN NEW-D DISPENSING KIT. Classified as Dialyzer Reprocessing System (product code LIF), Class II - Special Controls.

Submitted by Cobe Laboratories, Inc. (Lakewood, US). The FDA issued a Cleared decision on October 17, 1985 after a review of 35 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 Cobe Laboratories, Inc. devices

FDA 510(k) Submission Details - K853817

510(k) Number K853817 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 1985
Decision Date October 17, 1985
Days to Decision 35 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
95d faster than avg
Panel avg: 130d · This submission: 35d
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 26
Devices cleared under the same product code (LIF) and FDA review panel - the closest regulatory comparables to K853817.
FRESENIUS PURISTERIL 340 (TM)
K874573 · Seratronics, Inc. · Apr 1988
ADR-22 AUTOMATIC DIALYZER REPROCESSOR
K874034 · Biodynamics Corp. · Oct 1987
DRS-4 DIALYZER REPROCESSING SYSTEM
K860674 · Seratronics, Inc. · Apr 1986
RENATRON
K842258 · Renal Systems, Inc. · Jul 1984
HPR HOME PATIENT RENATRON
K833181 · Renal Systems, Inc. · Oct 1983
DIALYZER PREPARATION SYS DPS-4
K832230 · Seratronics, Inc. · Oct 1983