Cleared Traditional

K896763 - CATHETER ADAPTER CO-PAK CATALOG NO. 48-...

K896763 is the FDA 510(k) clearance for CATHETER ADAPTER CO-PAK CATALOG NO. 48-... by National Medical Care, Medical Products Div., Inc.. It is a Class 2 Gastroenterology & Urology device (product code KDJ) cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K896763 · National Medical Care, Medical Products Div., Inc. · Gastroenterology & Urology device
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Feb 1990
Decision
87d
Days
Class 2
Risk

K896763 is an FDA 510(k) clearance for the CATHETER ADAPTER CO-PAK CATALOG NO. 48-0122-1. Classified as Set, Administration, For Peritoneal Dialysis, Disposable (product code KDJ), Class II - Special Controls.

Submitted by National Medical Care, Medical Products Div., Inc. (Rockleigh, US). The FDA issued a Cleared decision on February 26, 1990 after a review of 87 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 National Medical Care, Medical Products Div., Inc. devices

Submission Details

510(k) Number K896763 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 1989
Decision Date February 26, 1990
Days to Decision 87 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
43d faster than avg
Panel avg: 130d · This submission: 87d
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 78
Devices cleared under the same product code (KDJ) and FDA review panel - the closest regulatory comparables to K896763.
CONVERTIBLE ADAPTER CATALOG NO. 48-4039-3
K900004 · National Medical Care, Medical Products Div., Inc. · Feb 1990
CATHETER ADAPTER SEALING CAP NO. 48-1028-9
K900006 · National Medical Care, Medical Products Div., Inc. · Feb 1990
TRANSFER SET SEALING CAP, CAT. NO. 48-1027-1
K896761 · National Medical Care, Medical Products Div., Inc. · Feb 1990
UNIVERSAL CONNECTOR CATALOG NO. 48-1025-5
K896764 · National Medical Care, Medical Products Div., Inc. · Feb 1990
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