Cleared Traditional

K900006 - CATHETER ADAPTER SEALING CAP NO. 48-1028-9

K900006 is the FDA 510(k) clearance for CATHETER ADAPTER SEALING CAP NO. 48-1028-9 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 56-day FDA review.

K900006 · National Medical Care, Medical Products Div., Inc. · Gastroenterology & Urology device
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Feb 1990
Decision
56d
Days
Class 2
Risk

K900006 is an FDA 510(k) clearance for the CATHETER ADAPTER SEALING CAP NO. 48-1028-9. 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 27, 1990 after a review of 56 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 K900006 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 02, 1990
Decision Date February 27, 1990
Days to Decision 56 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
74d faster than avg
Panel avg: 130d · This submission: 56d
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 K900006.
DEXTROLYTE II, MANUAL ADMINISTRATION SET 48-1032-1
K900005 · National Medical Care, Medical Products Div., Inc. · Mar 1990
QUICK DISCONNECT CLAMP CATALOG NO. 48-0300-3
K896956 · National Medical Care, Medical Products Div., Inc. · Feb 1990
CONVERTIBLE ADAPTER CATALOG NO. 48-4039-3
K900004 · 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
CATHETER ADAPTER CO-PAK CATALOG NO. 48-0122-1
K896763 · 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