Cleared Traditional

K850503 - SECU-TAPE UNIVERSAL FLEXIBLE MEDICAL CLAMPS

K850503 is an FDA 510(k) clearance for SECU-TAPE UNIVERSAL FLEXIBLE MEDICAL CLAMPS, manufactured by Turn Needle Intl., Inc.. The device is a Class 1 General Hospital device with product code KMK cleared through the Traditional 510(k) pathway after a 52-day FDA review.

K850503 · Turn Needle Intl., Inc. · General Hospital
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Apr 1985
Decision
52d
Days
Class 1
Risk

K850503 is an FDA 510(k) clearance for the SECU-TAPE UNIVERSAL FLEXIBLE MEDICAL CLAMPS. Classified as Device, Intravascular Catheter Securement (product code KMK), Class I - General Controls.

Submitted by Turn Needle Intl., Inc. (Miami Beach, US). The FDA issued a Cleared decision on April 1, 1985 after a review of 52 days - a notably fast clearance cycle.

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: 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 Turn Needle Intl., Inc. devices

FDA 510(k) Submission Details - K850503

510(k) Number K850503 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 1985
Decision Date April 01, 1985
Days to Decision 52 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
77d faster than avg
Panel avg: 129d · This submission: 52d
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 14
Devices cleared under the same product code (KMK) and FDA review panel - the closest regulatory comparables to K850503.
DESERET POSITIONAL SUTURE WING
K915495 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1992
TIMLEINE(TM) VENIPUNCTURE SYSTEM
K870770 · Ipax, Inc. · Apr 1987
SAFTI-BRACELET
K853418 · Advanced Biosearch Assn. · Sep 1985
ACU-DERM TRANSPARENT IV DRESSING
K842064 · Acme United Corp. · Aug 1984
AEGIS I.V. STRIPS
K812080 · Warner-Lambert Co. · Aug 1981
ADHESIVE I.V. CATHETER DRESSING
K810579 · Johnson & Johnson Professionals, Inc. · Mar 1981