Cleared Traditional

K850435 - SARTORIUS AQUASART SM 40035 - DIALYSATE...

K850435 is the FDA 510(k) clearance for SARTORIUS AQUASART SM 40035 - DIALYSATE... by Sartorius Filters, Inc.. It is a Class 2 Gastroenterology & Urology device (product code FKR) cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K850435 · Sartorius Filters, Inc. · Gastroenterology & Urology device
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Jun 1985
Decision
120d
Days
Class 2
Risk

K850435 is an FDA 510(k) clearance for the SARTORIUS AQUASART SM 40035 - DIALYSATE SYS. Classified as Subsystem, Proportioning (product code FKR), Class II - Special Controls.

Submitted by Sartorius Filters, Inc. (Hayward, US). The FDA issued a Cleared decision on June 4, 1985 after a review of 120 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Sartorius Filters, Inc. devices

Submission Details

510(k) Number K850435 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 1985
Decision Date June 04, 1985
Days to Decision 120 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
10d faster than avg
Panel avg: 130d · This submission: 120d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FKR Subsystem, Proportioning
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 - FKR Subsystem, Proportioning

All 11
Devices cleared under the same product code (FKR) and FDA review panel - the closest regulatory comparables to K850435.
NXSTAGE PUREFLOW SL
K080919 · Nxstage Medical, Inc. · Oct 2008
NXSTAGE DIALYSATE PREPARATION MODULE
K060296 · Nxstage Medical, Inc. · Mar 2006
NXSTAGE DIALYSATE PREPARATION MODULE, MODEL NX0269
K043436 · Nxstage Medical, Inc. · Mar 2005
AUTO-D AUTOMATIC DISINFECTION ACCESS/ATTACHMENTS
K850756 · Travenol Laboratories, S.A. · Mar 1985
CHEMATIC BICARBONATE DIALYSATE SYSTEM
K810605 · Trimedyne, Inc. · Jun 1981
GAMBRO BICARBONATE MODULE, BCM-10
K810127 · Gambro, Inc. · Feb 1981