Cleared Traditional

K923065 - BAXTER PERSONAL CYCLER AUTOMMATED PERIT...

K923065 is the FDA 510(k) clearance for BAXTER PERSONAL CYCLER AUTOMMATED PERIT... by Baxter Healthcare Corp. It is a Class 2 Gastroenterology & Urology device (product code FKX) cleared through the Traditional 510(k) pathway after a 617-day FDA review.

K923065 · Baxter Healthcare Corp · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1994
Decision
617d
Days
Class 2
Risk

K923065 is an FDA 510(k) clearance for the BAXTER PERSONAL CYCLER AUTOMMATED PERITONEAL DIAL. 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 March 4, 1994 after a review of 617 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Gastroenterology & Urology submissions.

View all Baxter Healthcare Corp devices

Submission Details

510(k) Number K923065 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 1992
Decision Date March 04, 1994
Days to Decision 617 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
487d slower than avg
Panel avg: 130d · This submission: 617d
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 45
Devices cleared under the same product code (FKX) and FDA review panel - the closest regulatory comparables to K923065.
HOMECHOICE PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM, MODELS 5C8310, 5C8302, 5C4471, 5C4469
K012988 · Baxter Healthcare Corp · Dec 2001
FRSENIUS PD IQCARD CYCLER
K002892 · Fresenius Medical Care North America · Apr 2001
BAXTER NIGHT EXCH DEVICE(NXD) PERITONEAL DIALY SYST
K935659 · Baxter Healthcare Corp · Jul 1994
R & D BATTERIES,INC. PART NUMBERS 5164, 5272, 5260
K933687 · R & D Batteries, Inc. · Feb 1994
NMC CYCLER MACHINE
K905809 · National Medical Care, Medical Products Div., Inc. · Feb 1992
ABBOTT INPERSOL CYCLER 1000
K895336 · Abbott Laboratories · Nov 1989