Cleared Traditional

K800993 - INPERSOL CAPD ADMIN. SET & CATHETER ADAP

K800993 is an FDA 510(k) clearance for INPERSOL CAPD ADMIN. SET & CATHETER ADAP, 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 109-day FDA review.

K800993 · Abbott Laboratories · Gastroenterology & Urology device
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Aug 1980
Decision
109d
Days
Class 2
Risk

K800993 is an FDA 510(k) clearance for the INPERSOL CAPD ADMIN. SET & CATHETER ADAP. 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 August 12, 1980 after a review of 109 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Abbott Laboratories devices

FDA 510(k) Submission Details - K800993

510(k) Number K800993 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 1980
Decision Date August 12, 1980
Days to Decision 109 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
21d faster than avg
Panel avg: 130d · This submission: 109d
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 K800993.
CCPD 3 LITER DRAINAGE SET
K810671 · American Medical Products, Inc. · Mar 1981
INPERSOL CAPD BAG PORT CLAMP
K803300 · Abbott Laboratories · Jan 1981
INPERSOL-CAPD ADMINISTRATION SET
K801881 · Abbott Laboratories · Oct 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
CONTINUOUS AMBULATORY DIALYSIS (CAPD)
K791512 · Norton Performance Plastics Corp. · Feb 1980