Cleared Traditional

K983480 - BPOS-IVAD STABILIZER

K983480 is an FDA 510(k) clearance for BPOS-IVAD STABILIZER, manufactured by Bpos, Inc.. The device is a Class 2 General Hospital device with product code LJT cleared through the Traditional 510(k) pathway after a 52-day FDA review.

K983480 · Bpos, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1998
Decision
52d
Days
Class 2
Risk

K983480 is an FDA 510(k) clearance for the BPOS-IVAD STABILIZER. Classified as Port & Catheter, Implanted, Subcutaneous, Intravascular (product code LJT), Class II - Special Controls.

Submitted by Bpos, Inc. (Aliso Viejo, US). The FDA issued a Cleared decision on November 23, 1998 after a review of 52 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 Bpos, Inc. devices

FDA 510(k) Submission Details - K983480

510(k) Number K983480 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 1998
Decision Date November 23, 1998
Days to Decision 52 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
77d faster than avg
Panel avg: 129d · This submission: 52d
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 218
Devices cleared under the same product code (LJT) and FDA review panel - the closest regulatory comparables to K983480.
PLASTIC PORT IMPLANTABLE VENOUS ACCESS SYSTEM
K994216 · Sims Deltec, Inc. · Jan 2000
PORT-A-CATH II TRANS-ARTERIAL PERCUTANEOUS SYSTEM
K992697 · Sims Deltec, Inc. · Nov 1999
P.A.S. PORT ELITE IMPLANTABLE VENOUS ACCESS SYSTEM
K992880 · Sims Deltec, Inc. · Oct 1999
VAXCEL IMPANTABLE VASCULAR ACCESS SYSTEM
K982888 · Boston Scientific Corp · Oct 1998
MINI POLYURETHANE CATHETER
K982507 · Med Institute, Inc. · Sep 1998
TRIMPORT
K974533 · Gerard Medical, Inc. · May 1998