Cleared Traditional

IMMOBILE STERILE AND IMMOBILE A/C STERILE (K941940) - FDA 510(k) Clearance

Class I General Hospital device.

K941940 · Tnt Moborg Intl. , Ltd. · General Hospital
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Jul 1994
Decision
84d
Days
Class 1
Risk

K941940 is an FDA 510(k) clearance for the IMMOBILE STERILE AND IMMOBILE A/C STERILE. Classified as Device, Intravascular Catheter Securement (product code KMK), Class I - General Controls.

Submitted by Tnt Moborg Intl. , Ltd. (Buffalo, US). The FDA issued a Cleared decision on July 14, 1994 after a review of 84 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 Tnt Moborg Intl. , Ltd. devices

Submission Details

510(k) Number K941940 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 21, 1994
Decision Date July 14, 1994
Days to Decision 84 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 129d · This submission: 84d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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

Devices cleared under the same product code (KMK) and FDA review panel - the closest regulatory comparables to K941940.
SecurAcath 10F, SecurAcath 12F, SecurAcath 5F, SecurAcath 5F, SecurAcath 6F, SecurAcath 7F/SecurAcath 8F
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