Cleared Traditional

K850756 - AUTO-D AUTOMATIC DISINFECTION ACCESS/AT...

K850756 is the FDA 510(k) clearance for AUTO-D AUTOMATIC DISINFECTION ACCESS/AT... by Travenol Laboratories, S.A.. It is a Class 2 Gastroenterology & Urology device (product code FKR) cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K850756 · Travenol Laboratories, S.A. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1985
Decision
23d
Days
Class 2
Risk

K850756 is an FDA 510(k) clearance for the AUTO-D AUTOMATIC DISINFECTION ACCESS/ATTACHMENTS. Classified as Subsystem, Proportioning (product code FKR), Class II - Special Controls.

Submitted by Travenol Laboratories, S.A. (Deerfield, US). The FDA issued a Cleared decision on March 20, 1985 after a review of 23 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 Travenol Laboratories, S.A. devices

Submission Details

510(k) Number K850756 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 1985
Decision Date March 20, 1985
Days to Decision 23 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
107d faster than avg
Panel avg: 130d · This submission: 23d
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 10
Devices cleared under the same product code (FKR) and FDA review panel - the closest regulatory comparables to K850756.
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
CHEMATIC BICARBONATE DIALYSATE SYSTEM
K810605 · Trimedyne, Inc. · Jun 1981
GAMBRO BICARBONATE MODULE, BCM-10
K810127 · Gambro, Inc. · Feb 1981
BICARB-O-MATE HEMODIALYSIS SOD. BICARB.
K802465 · Renal Systems, Inc. · Nov 1980