Cleared Traditional

K081889 - RHAPSODY CT

K081889 is an FDA 510(k) clearance for RHAPSODY CT, manufactured by Grantadler Corporation. The device is a Class 2 General Hospital device with product code LJT cleared through the Traditional 510(k) pathway after a 133-day FDA review.

K081889 · Grantadler Corporation · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2008
Decision
133d
Days
Class 2
Risk

K081889 is an FDA 510(k) clearance for the RHAPSODY CT. Classified as Port & Catheter, Implanted, Subcutaneous, Intravascular (product code LJT), Class II - Special Controls.

Submitted by Grantadler Corporation (Appollo Beach, US). The FDA issued a Cleared decision on November 12, 2008 after a review of 133 days - within the typical 510(k) review window.

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.

FDA 510(k) Submission Details - K081889

510(k) Number K081889 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 2008
Decision Date November 12, 2008
Days to Decision 133 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
4d slower than avg
Panel avg: 129d · This submission: 133d
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 282
Devices cleared under the same product code (LJT) and FDA review panel - the closest regulatory comparables to K081889.
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K091099 · Phs Medical GmbH · May 2009
POWERPORT DUO M.R.I. IMPLANTED PORT WITH 9.5 FR. DUAL LUMEN CHRONOFLEX POLYURETHANE CATHETER
K090512 · C.R. Bard, Inc. · Mar 2009
RHAPSODY MRI
K082126 · Grantadler Corporation · Nov 2008
COOK VASCULAR INC. VITAL-PORT VASCULAR ACCESS SYSTEM POWER INJECTABLE PORT
K081425 · Cook Vascular, Inc. · Sep 2008
SMARTPORT CT VORTEX
K081472 · AngioDynamics, Inc. · Sep 2008
POWERPORT IMPLANTED PORT WITH GROSHONG CATHETER
K081311 · C.R. Bard, Inc. · Jun 2008
K081889 · RHAPSODY CT
Download PDF FDA Summary Grantadler Corporation