Cleared Traditional

K803300 - INPERSOL CAPD BAG PORT CLAMP

K803300 is an FDA 510(k) clearance for INPERSOL CAPD BAG PORT CLAMP, 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 30-day FDA review.

K803300 · Abbott Laboratories · Gastroenterology & Urology device
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Jan 1981
Decision
30d
Days
Class 2
Risk

K803300 is an FDA 510(k) clearance for the INPERSOL CAPD BAG PORT CLAMP. 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 January 29, 1981 after a review of 30 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 - K803300

510(k) Number K803300 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 1980
Decision Date January 29, 1981
Days to Decision 30 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
100d faster than avg
Panel avg: 130d · This submission: 30d
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 K803300.
AMP PERITONEAL DIALYSIS PREP KIT
K810840 · American Medical Products, Inc. · Apr 1981
CCPD CYCLER SET
K810670 · American Medical Products, Inc. · Mar 1981
CCPD 3 LITER DRAINAGE SET
K810671 · American Medical Products, Inc. · Mar 1981
INPERSOL-CAPD ADMINISTRATION SET
K801881 · Abbott Laboratories · Oct 1980
INPERSOL CAPD ADMIN. SET & CATHETER ADAP
K800993 · Abbott Laboratories · Aug 1980
CLIRANS TE15 HOLLOW FIBER DIALYZER
K801193 · Terumo America, Inc. · Aug 1980