Cleared Traditional

K830689 - EMPTY DIALYSATE CONTAINER BB-69

K830689 is an FDA 510(k) clearance for EMPTY DIALYSATE CONTAINER BB-69, manufactured by Delmed, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FKX cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K830689 · Delmed, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1983
Decision
42d
Days
Class 2
Risk

K830689 is an FDA 510(k) clearance for the EMPTY DIALYSATE CONTAINER BB-69. Classified as System, Peritoneal, Automatic Delivery (product code FKX), Class II - Special Controls.

Submitted by Delmed, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 29, 1983 after a review of 42 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5630 - 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 Delmed, Inc. devices

FDA 510(k) Submission Details - K830689

510(k) Number K830689 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 15, 1983
Decision Date March 29, 1983
Days to Decision 42 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
89d faster than avg
Panel avg: 131d · This submission: 42d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FKX Device Classification - Class 2, Special Controls

Product Code FKX System, Peritoneal, Automatic Delivery
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5630
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 - FKX System, Peritoneal, Automatic Delivery

All 60
Devices cleared under the same product code (FKX) and FDA review panel - the closest regulatory comparables to K830689.
CAPD ULTRAVIOLET GERMICIDAL EXCHANGE
K833595 · Travenol Laboratories, S.A. · Nov 1983
AUTOMATIC PERITONEAL DIALYSIS CYCLER
K833065 · Travenol Laboratories, S.A. · Nov 1983
AMPERCIDE DISINFECTANT ACCESSORY TO -
K830881 · American Medical Products, Inc. · Jun 1983
ABBOTT PATIENT ASSIST DEVICE
K830766 · Abbott Laboratories · Mar 1983
AMP 80/2 OUTFLOW MONITOR MODIFICATION
K823827 · American Medical Products, Inc. · Mar 1983
BETA-CAP D ADAPTER
K830208 · Quinton, Inc. · Mar 1983