Cleared Traditional

ABBOTT INPERSOL CYCLER 1000 (K895336) - FDA 510(k) Clearance

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

K895336 · Abbott Laboratories · Gastroenterology & Urology device
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Nov 1989
Decision
89d
Days
Class 2
Risk

K895336 is an FDA 510(k) clearance for the ABBOTT INPERSOL CYCLER 1000. Classified as System, Peritoneal, Automatic Delivery (product code FKX), Class II - Special Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on November 28, 1989 after a review of 89 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 Abbott Laboratories devices

Submission Details

510(k) Number K895336 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 1989
Decision Date November 28, 1989
Days to Decision 89 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 130d · This submission: 89d
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 36
Devices cleared under the same product code (FKX) and FDA review panel - the closest regulatory comparables to K895336.
HOMECHOICE PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM, MODELS 5C8310, 5C8302, 5C4471, 5C4469
K012988 · Baxter Healthcare Corp · Dec 2001
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
PERITONEAL CATHETER STABILIZATION DEVICE 5C4381
K884554 · Baxter Healthcare Corp · Jan 1989
BENT NECK CURLCATH PERITONEAL DIALYSIS KIT
K874632 · Quinton, Inc. · Dec 1987
UPGRADED AUTO PERITONEAL DIALYSIS CYCLER SYSTEM
K872652 · Travenol Laboratories, S.A. · Sep 1987