Cleared Traditional

NORFOLK MEDICAL PERITONEAL-ACCESS PORT (K854593) - FDA 510(k) Clearance

Class III device cleared through the 510(k) pathway via substantial equivalence to a legally marketed predicate.

K854593 · Norfolk Medical Products, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1986
Decision
78d
Days
Class 3
Risk

K854593 is an FDA 510(k) clearance for the NORFOLK MEDICAL PERITONEAL-ACCESS PORT. Classified as Device, Peritoneal Access, Subcutaneous, Implanted (product code LMQ), Class III - Premarket Approval.

Submitted by Norfolk Medical Products, Inc. (Skokie, US). The FDA issued a Cleared decision on February 4, 1986 after a review of 78 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. High regulatory complexity profile. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Norfolk Medical Products, Inc. devices

Submission Details

510(k) Number K854593 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 1985
Decision Date February 04, 1986
Days to Decision 78 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
51d faster than avg
Panel avg: 129d · This submission: 78d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LMQ Device, Peritoneal Access, Subcutaneous, Implanted
Device Class Class 3 - Premarket Approval
What this classification means

Class III devices typically require Premarket Approval (PMA) with clinical evidence. Clearance through 510(k) for Class III devices is granted only when substantial equivalence to a valid predicate can be established.