Cleared Traditional

K801881 - INPERSOL-CAPD ADMINISTRATION SET

K801881 is an FDA 510(k) clearance for INPERSOL-CAPD ADMINISTRATION SET, manufactured by Abbott Laboratories. The device is a Class 2 Gastroenterology & Urology device with product code KDJ cleared through the Traditional 510(k) pathway after a 64-day FDA review.

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

FDA 510(k) Submission Details - K801881

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.

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 93
Devices cleared under the same product code (KDJ) and FDA review panel - the closest regulatory comparables to K801881.
CCPD CYCLER SET
K810670 · American Medical Products, Inc. · Mar 1981
CCPD 3 LITER DRAINAGE SET
K810671 · American Medical Products, Inc. · Mar 1981
INPERSOL CAPD BAG PORT CLAMP
K803300 · Abbott Laboratories · Jan 1981
INPERSOL CAPD ADMIN. SET & CATHETER ADAP
K800993 · Abbott Laboratories · Aug 1980
CLIRANS TE15 HOLLOW FIBER DIALYZER
K801193 · Terumo America, Inc. · Aug 1980
PERITONEAL DIALYSIS CYCLER SET W/PUMP
K801220 · American Medical Products, Inc. · Aug 1980