Cleared Traditional

K873984 - AUTOMATIC PERITONEAL DIALYSIS CYCLER SET (5C4437)

K873984 is an FDA 510(k) clearance for AUTOMATIC PERITONEAL DIALYSIS CYCLER SE..., manufactured by Travenol Laboratories, S.A.. The device is a Class 2 Gastroenterology & Urology device with product code KDJ cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K873984 · Travenol Laboratories, S.A. · Gastroenterology & Urology device
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Oct 1987
Decision
20d
Days
Class 2
Risk

K873984 is an FDA 510(k) clearance for the AUTOMATIC PERITONEAL DIALYSIS CYCLER SET (5C4437). Classified as Set, Administration, For Peritoneal Dialysis, Disposable (product code KDJ), Class II - Special Controls.

Submitted by Travenol Laboratories, S.A. (Round Lake, US). The FDA issued a Cleared decision on October 20, 1987 after a review of 20 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 Travenol Laboratories, S.A. devices

FDA 510(k) Submission Details - K873984

510(k) Number K873984 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 1987
Decision Date October 20, 1987
Days to Decision 20 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
111d faster than avg
Panel avg: 131d · This submission: 20d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KDJ Device Classification - Class 2, Special Controls

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 100
Devices cleared under the same product code (KDJ) and FDA review panel - the closest regulatory comparables to K873984.
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