Cleared Traditional

PERITONEAL CATHETER STABILIZATION DEVICE 5C4381 (K884554) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K884554 · Baxter Healthcare Corp · Gastroenterology & Urology device
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Jan 1989
Decision
92d
Days
Class 2
Risk

K884554 is an FDA 510(k) clearance for the PERITONEAL CATHETER STABILIZATION DEVICE 5C4381. Classified as System, Peritoneal, Automatic Delivery (product code FKX), Class II - Special Controls.

Submitted by Baxter Healthcare Corp (Round Lake, US). The FDA issued a Cleared decision on January 31, 1989 after a review of 92 days - within the typical 510(k) review window.

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: 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 Baxter Healthcare Corp devices

Submission Details

510(k) Number K884554 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 1988
Decision Date January 31, 1989
Days to Decision 92 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
38d faster than avg
Panel avg: 130d · This submission: 92d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 31
Devices cleared under the same product code (FKX) and FDA review panel - the closest regulatory comparables to K884554.
BAXTER NIGHT EXCH DEVICE(NXD) PERITONEAL DIALY SYST
K935659 · Baxter Healthcare Corp · Jul 1994
BAXTER PERSONAL CYCLER AUTOMMATED PERITONEAL DIAL
K923065 · Baxter Healthcare Corp · Mar 1994
ABBOTT INPERSOL CYCLER 1000
K895336 · Abbott Laboratories · Nov 1989
UPGRADED AUTO PERITONEAL DIALYSIS CYCLER SYSTEM
K872652 · Travenol Laboratories, S.A. · Sep 1987
ABBOTT INPERSOL CYCLER 1000
K845042 · Abbott Laboratories · Mar 1985
AUTOMATIC PERITONEAL DIALYSIS CYCLER SYSTEM
K850406 · Travenol Laboratories, S.A. · Feb 1985