Cleared Traditional

INPERSOL-CAPD ADMINISTRATION SET (K801881) - FDA 510(k) Clearance

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

K801881 · Abbott Laboratories · Gastroenterology & Urology device
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Oct 1980
Decision
64d
Days
Class 2
Risk

K801881 is an FDA 510(k) clearance for the INPERSOL-CAPD ADMINISTRATION SET. Classified as Set, Administration, For Peritoneal Dialysis, Disposable (product code KDJ), Class II - Special Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on October 10, 1980 after a review of 64 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 K801881 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 1980
Decision Date October 10, 1980
Days to Decision 64 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
66d faster than avg
Panel avg: 130d · This submission: 64d
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 37
Devices cleared under the same product code (KDJ) and FDA review panel - the closest regulatory comparables to K801881.
CARD U.V. GERMICIDAL CHAMBER II
K820546 · Travenol Laboratories, S.A. · Jun 1982
CAPD U.V. GERMICIDAL CONNECTION SYSTEM
K812802 · Travenol Laboratories, S.A. · Mar 1982
INPERSOL CAPD BAG PORT CLAMP
K803300 · Abbott Laboratories · Jan 1981
INPERSOL CAPD ADMIN. SET & CATHETER ADAP
K800993 · Abbott Laboratories · Aug 1980
CAPD TRANSFER SET JC9044
K792651 · Travenol Laboratories, S.A. · Feb 1980
CYCLER SETS MOD. #5C4143, 5C4144, 5C4145
K791899 · Travenol Laboratories, S.A. · Nov 1979