Cleared Traditional

CAPD ULTRAVIOLET(U.V.) GERMICIDAL EXCHANGE DEV SYS (K883239) - FDA 510(k) Clearance

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

K883239 · Baxter Healthcare Corp · Gastroenterology & Urology device
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Oct 1988
Decision
81d
Days
Class 2
Risk

K883239 is an FDA 510(k) clearance for the CAPD ULTRAVIOLET(U.V.) GERMICIDAL EXCHANGE DEV SYS. Classified as Set, Administration, For Peritoneal Dialysis, Disposable (product code KDJ), Class II - Special Controls.

Submitted by Baxter Healthcare Corp (Round Lake, US). The FDA issued a Cleared decision on October 21, 1988 after a review of 81 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 Baxter Healthcare Corp devices

Submission Details

510(k) Number K883239 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 1988
Decision Date October 21, 1988
Days to Decision 81 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
49d faster than avg
Panel avg: 130d · This submission: 81d
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 36
Devices cleared under the same product code (KDJ) and FDA review panel - the closest regulatory comparables to K883239.
DISCONNECT CAPS PRODUCT CODES 5C4212 AND 5C4466
K895631 · Baxter Healthcare Corp · Jan 1990
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
EXTENDED LIFE CAPD SOLUTION TRANSFER SET IC4373
K882455 · Baxter Healthcare Corp · Jul 1988
EXTENDED LIFE CAPD TRANSFER SET 5C4444
K882498 · Baxter Healthcare Corp · Jul 1988
AUTOMATIC PERITONEAL DIALYSIS CYCLER SET (5C4437)
K873984 · Travenol Laboratories, S.A. · Oct 1987