Cleared Traditional

K810605 - CHEMATIC BICARBONATE DIALYSATE SYSTEM

K810605 is an FDA 510(k) clearance for CHEMATIC BICARBONATE DIALYSATE SYSTEM, manufactured by Trimedyne, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FKR cleared through the Traditional 510(k) pathway after a 102-day FDA review.

K810605 · Trimedyne, Inc. · Gastroenterology & Urology device
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Jun 1981
Decision
102d
Days
Class 2
Risk

K810605 is an FDA 510(k) clearance for the CHEMATIC BICARBONATE DIALYSATE SYSTEM. Classified as Subsystem, Proportioning (product code FKR), Class II - Special Controls.

Submitted by Trimedyne, Inc. (Walker, US). The FDA issued a Cleared decision on June 16, 1981 after a review of 102 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 Trimedyne, Inc. devices

FDA 510(k) Submission Details - K810605

510(k) Number K810605 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 1981
Decision Date June 16, 1981
Days to Decision 102 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
28d faster than avg
Panel avg: 130d · This submission: 102d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FKR Device Classification - Class 2, Special Controls

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 10
Devices cleared under the same product code (FKR) and FDA review panel - the closest regulatory comparables to K810605.
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
GAMBRO BICARBONATE MODULE, BCM-10
K810127 · Gambro, Inc. · Feb 1981
BICARB-O-MATE HEMODIALYSIS SOD. BICARB.
K802465 · Renal Systems, Inc. · Nov 1980
MOD. DM-357 BICARBONATE RETROFIT KIT
K800772 · Extracorporeal Medical Specialities, Inc. · May 1980