Cleared Traditional

K892871 - PERITONEAL DIALYSIS CYCLER SET

K892871 is the FDA 510(k) clearance for PERITONEAL DIALYSIS CYCLER SET by National Medical Care, Medical Products Div., Inc.. It is a Class 2 Gastroenterology & Urology device (product code KDJ) cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K892871 · National Medical Care, Medical Products Div., Inc. · Gastroenterology & Urology device
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May 1989
Decision
29d
Days
Class 2
Risk

K892871 is an FDA 510(k) clearance for the PERITONEAL DIALYSIS CYCLER SET, W/8 PRONG MANIFOLD. Classified as Set, Administration, For Peritoneal Dialysis, Disposable (product code KDJ), Class II - Special Controls.

Submitted by National Medical Care, Medical Products Div., Inc. (Rockleigh, US). The FDA issued a Cleared decision on May 18, 1989 after a review of 29 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 National Medical Care, Medical Products Div., Inc. devices

Submission Details

510(k) Number K892871 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 19, 1989
Decision Date May 18, 1989
Days to Decision 29 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
101d faster than avg
Panel avg: 130d · This submission: 29d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 78
Devices cleared under the same product code (KDJ) and FDA review panel - the closest regulatory comparables to K892871.
CONNECTION SHIELDS CODES 5C4213 AND 5C4215
K895673 · Baxter Healthcare Corp · Jan 1990
PERITONEAL DIAL. TITA. CATH ADAPTER & LOCKING CAP
K894783 · Baxter Healthcare Corp · Sep 1989
PERITONEAL DIALYSIS CYCLER SET, W/5 PRONG MANIFOLD
K892870 · National Medical Care, Medical Products Div., Inc. · May 1989
PERITONEAL DIALYSIS CYCLER SET W/12 PRONG MANIFOLD
K892872 · National Medical Care, Medical Products Div., Inc. · May 1989
CAPD ULTRAVIOLET(U.V.) GERMICIDAL EXCHANGE DEV SYS
K883239 · Baxter Healthcare Corp · Oct 1988
EXTENDED LIFE CAPD SOLUTION TRANSFER SET IC4373
K882455 · Baxter Healthcare Corp · Jul 1988