Cleared Traditional

K811294 - GAMBRO PERITONEAL DIALYSIS FLUID LINES

K811294 is an FDA 510(k) clearance for GAMBRO PERITONEAL DIALYSIS FLUID LINES, manufactured by Gambro, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KDJ cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K811294 · Gambro, Inc. · Gastroenterology & Urology device
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Jun 1981
Decision
32d
Days
Class 2
Risk

K811294 is an FDA 510(k) clearance for the GAMBRO PERITONEAL DIALYSIS FLUID LINES. Classified as Set, Administration, For Peritoneal Dialysis, Disposable (product code KDJ), Class II - Special Controls.

Submitted by Gambro, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 12, 1981 after a review of 32 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 Gambro, Inc. devices

FDA 510(k) Submission Details - K811294

510(k) Number K811294 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 1981
Decision Date June 12, 1981
Days to Decision 32 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
98d faster than avg
Panel avg: 130d · This submission: 32d
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 93
Devices cleared under the same product code (KDJ) and FDA review panel - the closest regulatory comparables to K811294.
CARD U.V. GERMICIDAL CHAMBER II
K820546 · Travenol Laboratories, S.A. · Jun 1982
CAPD U.V. GERMICIDAL CONNECTION SYSTEM
K812802 · Travenol Laboratories, S.A. · Mar 1982
PERITONEAL DIALYSIS CYCLER SET
K813069 · American Medical Products, Inc. · Nov 1981
AMP PERITONEAL DIALYSIS PREP KIT
K810840 · American Medical Products, Inc. · Apr 1981
CCPD CYCLER SET
K810670 · American Medical Products, Inc. · Mar 1981
CCPD 3 LITER DRAINAGE SET
K810671 · American Medical Products, Inc. · Mar 1981