Cleared Traditional

K770119 - I.V. LOK TM

K770119 is an FDA 510(k) clearance for I.V. LOK TM, manufactured by Jelco Laboratories. 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.

K770119 · Jelco Laboratories · General Hospital
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Mar 1977
Decision
52d
Days
Class 1
Risk

K770119 is an FDA 510(k) clearance for the I.V. LOK TM. Classified as Device, Intravascular Catheter Securement (product code KMK), Class I - General Controls.

Submitted by Jelco Laboratories (Mchenry, US). The FDA issued a Cleared decision on March 14, 1977 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 Jelco Laboratories devices

FDA 510(k) Submission Details - K770119

510(k) Number K770119 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 1977
Decision Date March 14, 1977
Days to Decision 52 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
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.