Cleared Traditional

K873575 - UNIPORT MODELS SD-90

K873575 is an FDA 510(k) clearance for UNIPORT MODELS SD-90, manufactured by Healthcare Technologies, Inc.. The device is a Class 2 General Hospital device with product code LJT cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K873575 · Healthcare Technologies, Inc. · General Hospital
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Nov 1987
Decision
80d
Days
Class 2
Risk

K873575 is an FDA 510(k) clearance for the UNIPORT MODELS SD-90, TD-60, TD-70 & TD-90. Classified as Port & Catheter, Implanted, Subcutaneous, Intravascular (product code LJT), Class II - Special Controls.

Submitted by Healthcare Technologies, Inc. (Skokie, US). The FDA issued a Cleared decision on November 13, 1987 after a review of 80 days - a notably fast clearance cycle.

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: 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 Healthcare Technologies, Inc. devices

FDA 510(k) Submission Details - K873575

510(k) Number K873575 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 1987
Decision Date November 13, 1987
Days to Decision 80 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
49d faster than avg
Panel avg: 129d · This submission: 80d
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 170
Devices cleared under the same product code (LJT) and FDA review panel - the closest regulatory comparables to K873575.
PORT-A-CATH(R) IMPLANTABLE DRUG DELIVERY SYSTEM
K875276 · Pharmacia Deltec, Inc. · Apr 1988
A PORT IMPLANTABLE VASCULAR ACCESS SYSTEM
K875214 · Therex Corp. · Feb 1988
CHEMO-PORT
K874184 · Hdc Corp. · Dec 1987
MEDTRONIC CATHETER ACCESS PORT MODEL 8500
K873735 · Medtronic Vascular · Nov 1987
HICKMAN PLASTIC SUBCUTANEOUS PORT
K873213 · C.R. Bard, Inc. · Oct 1987
MEDIPORT II MODEL MP-DL VASCULAR ACCESS PORT
K870817 · C.R. Bard, Inc. · Jul 1987