Cleared Traditional

K981860 - A P HARNESS

K981860 is an FDA 510(k) clearance for A P HARNESS, manufactured by Paraworks Enterprise, Ltd.. The device is a Class 1 General Hospital device with product code KMK cleared through the Traditional 510(k) pathway after a 372-day FDA review.

K981860 · Paraworks Enterprise, Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1999
Decision
372d
Days
Class 1
Risk

K981860 is an FDA 510(k) clearance for the A P HARNESS. Classified as Device, Intravascular Catheter Securement (product code KMK), Class I - General Controls.

Submitted by Paraworks Enterprise, Ltd. (Vancouver, British Columbia, CA). The FDA issued a Cleared decision on June 3, 1999 after a review of 372 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5210 - the FDA general hospital 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. Elevated predicate reliance 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 Paraworks Enterprise, Ltd. devices

FDA 510(k) Submission Details - K981860

510(k) Number K981860 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 27, 1998
Decision Date June 03, 1999
Days to Decision 372 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
243d slower than avg
Panel avg: 129d · This submission: 372d
Pathway characteristics
Predicate-based equivalence.

KMK Device Classification - Class 1, General Controls

Product Code KMK Device, Intravascular Catheter Securement
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.5210
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - KMK Device, Intravascular Catheter Securement

All 13
Devices cleared under the same product code (KMK) and FDA review panel - the closest regulatory comparables to K981860.
SecurAcath 10F, SecurAcath 12F, SecurAcath 5F, SecurAcath 5F, SecurAcath 6F, SecurAcath 7F/SecurAcath 8F
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