Cleared Traditional

K910448 - SNAP-LOCK MICRO PORT, MODIFICATION

K910448 is an FDA 510(k) clearance for SNAP-LOCK MICRO PORT, manufactured by Infusaid Corp.. The device is a Class 2 General Hospital device with product code LJT cleared through the Traditional 510(k) pathway after a 303-day FDA review.

K910448 · Infusaid Corp. · General Hospital
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Nov 1991
Decision
303d
Days
Class 2
Risk

K910448 is an FDA 510(k) clearance for the SNAP-LOCK MICRO PORT, MODIFICATION. Classified as Port & Catheter, Implanted, Subcutaneous, Intravascular (product code LJT), Class II - Special Controls.

Submitted by Infusaid Corp. (Norwood, US). The FDA issued a Cleared decision on November 21, 1991 after a review of 303 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5965 - 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 Infusaid Corp. devices

FDA 510(k) Submission Details - K910448

510(k) Number K910448 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 1991
Decision Date November 21, 1991
Days to Decision 303 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
174d slower than avg
Panel avg: 129d · This submission: 303d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LJT Device Classification - Class 2, Special Controls

Product Code LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5965
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - LJT Port & Catheter, Implanted, Subcutaneous, Intravascular

All 244
Devices cleared under the same product code (LJT) and FDA review panel - the closest regulatory comparables to K910448.
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