Cleared Traditional

K912208 - FRESENIUS SAFE-CONNECT CAPD MANUAL ASSI...

K912208 is an FDA 510(k) clearance for FRESENIUS SAFE-CONNECT CAPD MANUAL ASSI..., manufactured by Fresenius USA, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KDJ cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K912208 · Fresenius USA, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1991
Decision
65d
Days
Class 2
Risk

K912208 is an FDA 510(k) clearance for the FRESENIUS SAFE-CONNECT CAPD MANUAL ASSIST DEVICE. Classified as Set, Administration, For Peritoneal Dialysis, Disposable (product code KDJ), Class II - Special Controls.

Submitted by Fresenius USA, Inc. (Concord, US). The FDA issued a Cleared decision on July 24, 1991 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 876.5630 - 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 Fresenius USA, Inc. devices

FDA 510(k) Submission Details - K912208

510(k) Number K912208 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 1991
Decision Date July 24, 1991
Days to Decision 65 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
65d faster than avg
Panel avg: 130d · This submission: 65d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KDJ Device Classification - Class 2, Special Controls

Product Code KDJ Set, Administration, For Peritoneal Dialysis, Disposable
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 - KDJ Set, Administration, For Peritoneal Dialysis, Disposable

All 94
Devices cleared under the same product code (KDJ) and FDA review panel - the closest regulatory comparables to K912208.
DEXTROLYTE II PERITONEAL DIALYSIS ADMIN. SET
K920586 · National Medical Care, Medical Products Div., Inc. · Sep 1992
DEXTROLYTE II PERITONEAL DIALYSIS PUMP
K915628 · National Medical Care, Medical Products Div., Inc. · Mar 1992
ABBOTT SMART CAP
K915304 · Abbott Laboratories · Feb 1992
CAPD SAFELOCK TRANSFER SET W/PRE-FILLED CONNECTOR
K904806 · Fresenius USA, Inc. · Jan 1991
CAPD DISPOSABLE DISCONNECT Y-SET CODE: 5C4481
K902526 · Baxter Healthcare Corp · Nov 1990
LONG-LIFE Y-SET CAT. NO. 48-6366-8
K902451 · National Medical Care, Medical Products Div., Inc. · Aug 1990