Cleared Traditional

K932509 - STRATO MEDICAL INFUSE-A-PORT/SNAP-LOCK MACROPRORT

K932509 is an FDA 510(k) clearance for STRATO MEDICAL INFUSE-A-PORT/SNAP-LOCK ..., manufactured by Strato Medical Corp.. The device is a Class 2 General Hospital device with product code LJT cleared through the Traditional 510(k) pathway after a 227-day FDA review.

K932509 · Strato Medical Corp. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1994
Decision
227d
Days
Class 2
Risk

K932509 is an FDA 510(k) clearance for the STRATO MEDICAL INFUSE-A-PORT/SNAP-LOCK MACROPRORT. 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 January 7, 1994 after a review of 227 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. 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 Strato Medical Corp. devices

FDA 510(k) Submission Details - K932509

510(k) Number K932509 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 25, 1993
Decision Date January 07, 1994
Days to Decision 227 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
98d slower than avg
Panel avg: 129d · This submission: 227d
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 238
Devices cleared under the same product code (LJT) and FDA review panel - the closest regulatory comparables to K932509.
THEREX LOW-PROFILE PORT .6MM I.D 2.3MM O.D.
K932447 · Therex Corp. · Feb 1994
THEREX R-PORT
K932671 · Therex Corp. · Feb 1994
V.A.D. ACCESS KIT
K932010 · Clinipad Corp. · Feb 1994
PORT-A-CATH DUAL LUMEN IMPLANTABLE VENOUS ACCESS S
K932095 · Pharmacia Deltec, Inc. · Jan 1994
PORT-A-CATH IMPLANTABLE VASCULAR ACCESS SYSTEM
K932840 · Pharmacia Deltec, Inc. · Jan 1994
PORT-A-CATH DUAL LUMEN IMPLANTABLE VENOUS ACCESS
K932841 · Pharmacia Deltec, Inc. · Jan 1994