Cleared Traditional

K850127 - FORMA-TAG USP SODIUM CHLORIDE PACKAGE 80GM & 120 G

K850127 is an FDA 510(k) clearance for FORMA-TAG USP SODIUM CHLORIDE PACKAGE 8..., manufactured by Computer Dialysis Systems, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code LIF cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K850127 · Computer Dialysis Systems, Inc. · Gastroenterology & Urology device
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Mar 1985
Decision
65d
Days
Class 2
Risk

K850127 is an FDA 510(k) clearance for the FORMA-TAG USP SODIUM CHLORIDE PACKAGE 80GM & 120 G. Classified as Dialyzer Reprocessing System (product code LIF), Class II - Special Controls.

Submitted by Computer Dialysis Systems, Inc. (Boulder, US). The FDA issued a Cleared decision on March 20, 1985 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 876.5820 - 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 Computer Dialysis Systems, Inc. devices

FDA 510(k) Submission Details - K850127

510(k) Number K850127 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 14, 1985
Decision Date March 20, 1985
Days to Decision 65 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
66d faster than avg
Panel avg: 131d · This submission: 65d
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 33
Devices cleared under the same product code (LIF) and FDA review panel - the closest regulatory comparables to K850127.
ADR-22 AUTOMATIC DIALYZER REPROCESSOR
K874034 · Biodynamics Corp. · Oct 1987
DRS-4 DIALYZER REPROCESSING SYSTEM
K860674 · Seratronics, Inc. · Apr 1986
COBE REN NEW-D DISPENSING KIT
K853817 · Cobe Laboratories, Inc. · Oct 1985
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