Cleared Traditional

LIFEPORT ATTACHABLE SYSTEM W/INDUCER KIT LPS 5555 (K915273) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K915273 · Strato Medical Corp. · General Hospital
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Jul 1993
Decision
590d
Days
Class 2
Risk

K915273 is an FDA 510(k) clearance for the LIFEPORT ATTACHABLE SYSTEM W/INDUCER KIT LPS 5555. Classified as Port & Catheter, Implanted, Subcutaneous, Intravascular (product code LJT), Class II - Special Controls.

Submitted by Strato Medical Corp. (Beverly, US). The FDA issued a Cleared decision on July 7, 1993 after a review of 590 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Strato Medical Corp. devices

Submission Details

510(k) Number K915273 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received November 25, 1991
Decision Date July 07, 1993
Days to Decision 590 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
461d slower than avg
Panel avg: 129d · This submission: 590d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 42
Devices cleared under the same product code (LJT) and FDA review panel - the closest regulatory comparables to K915273.
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MEDTRONIC CATHETER ACCESS PORT MODEL 8500
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HICKMAN PLASTIC SUBCUTANEOUS PORT
K873213 · C.R. Bard, Inc. · Oct 1987
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K870817 · C.R. Bard, Inc. · Jul 1987