Cleared Traditional

K905809 - NMC CYCLER MACHINE

K905809 is the FDA 510(k) clearance for NMC CYCLER MACHINE by National Medical Care, Medical Products Div., Inc.. It is a Class 2 Gastroenterology & Urology device (product code FKX) cleared through the Traditional 510(k) pathway after a 425-day FDA review.

K905809 · National Medical Care, Medical Products Div., Inc. · Gastroenterology & Urology device
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Feb 1992
Decision
425d
Days
Class 2
Risk

K905809 is an FDA 510(k) clearance for the NMC CYCLER MACHINE. Classified as System, Peritoneal, Automatic Delivery (product code FKX), Class II - Special Controls.

Submitted by National Medical Care, Medical Products Div., Inc. (Rockleigh, US). The FDA issued a Cleared decision on February 25, 1992 after a review of 425 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 National Medical Care, Medical Products Div., Inc. devices

Submission Details

510(k) Number K905809 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 1990
Decision Date February 25, 1992
Days to Decision 425 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
295d slower than avg
Panel avg: 130d · This submission: 425d
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 K905809.
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
R & D BATTERIES,INC. PART NUMBERS 5164, 5272, 5260
K933687 · R & D Batteries, Inc. · Feb 1994
ABBOTT INPERSOL CYCLER 1000
K895336 · Abbott Laboratories · Nov 1989
PERITONEAL CATHETER STABILIZATION DEVICE 5C4381
K884554 · Baxter Healthcare Corp · Jan 1989
BENT NECK CURLCATH PERITONEAL DIALYSIS KIT
K874632 · Quinton, Inc. · Dec 1987