510(k) · Cleared
ClearedGrantalder Rhapsody Access Port and Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Grantadler Corportation · LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
Cleared on Feb 2, 2006 as substantially equivalent to K951814 (Horizon Medical Products, Inc., 1995) after a 443-day review. Its family tree reaches back 1 generation to 1995. 4 later devices descend from it.
- Decided
- Feb 2, 2006
- Review
- 443 days
- Class
- Class II
- Product code
- LJT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K951814 (1995). 4 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK951814 Triumph-1 PortHorizon Medical Products, Inc. · 1995 · Recalled
- This deviceK043178 Grantalder Rhapsody Access Port and CatheterGrantadler Corportation · 2006
- Descendant · cites it directly · 1 of its ownK110407 InvisiportStealth Therapeutics, Incorporated · 2011
- Descendant · 2 generations on · 0 of its ownK141146 InvisiportStealth Therapeutics, Incorporated · 2015
- Descendant · cites it directly · 0 of its ownK082126 Rhapsody MriGrantadler Corporation · 2008
- Descendant · cites it directly · 0 of its ownK081889 Rhapsody CTGrantadler Corporation · 2008
Most influential descendants
Showing 4 of 4 · See all- K110407InvisiportStealth Therapeutics, Incorporated · 2011 · cites it directly1descendant
- K141146InvisiportStealth Therapeutics, Incorporated · 2015 · 2 generations on0descendants
- K082126Rhapsody MriGrantadler Corporation · 2008 · cites it directly0descendants
- K081889Rhapsody CTGrantadler Corporation · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K951814 | Triumph-1 Port | Horizon Medical Products, Inc. | 1995 | 1 |
| 0 (this device) | K043178 | Grantalder Rhapsody Access Port and Catheter | Grantadler Corportation | 2006 | — |
| +1 | K110407 | Invisiport | Stealth Therapeutics, Incorporated | 2011 | — |
| +2 | K141146 | Invisiport | Stealth Therapeutics, Incorporated | 2015 | — |
| +1 | K082126 | Rhapsody Mri | Grantadler Corporation | 2008 | — |
| +1 | K081889 | Rhapsody CT | Grantadler Corporation | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 2 | 0 |
| 2011 | 1 | 0 |
| 2015 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LJT? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LJT device
- #1 K251253 PowerPort™ isp Implantable Port; PowerPort™…score 14.9 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K951814 | Triumph-1 PortSummary page 2…fascia. The grantAdler Implantable Access Ports have the same descriptive and technological characteristics as the Horizon Medical Products, Inc. (HMP) Triumph-I Ports K951814 and numerous other implantable access ports on the market today. PERFORMANCE CHARACTERISTICS Laboratory testing regarding char… | 1995 |
What descends from it? (4)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All LJT devicesLJT Port & Catheter, Implanted, Subcutaneous, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LJT
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LJT
182in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LJT
1in 2022
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · LJT
4,308in 2025
MAUDE reports naming product code LJT, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 11 | 85 | 1 | 208 |
| 2008 | 7 | 119 | 2 | 161 |
| 2009 | 2 | — | 2 | 172 |
| 2010 | 2 | — | 19 | 207 |
| 2011 | 5 | 144 | 1 | 202 |
| 2012 | 2 | — | 2 | 153 |
| 2013 | 7 | 150 | 0 | 141 |
| 2014 | 2 | — | 0 | 143 |
| 2015 | 4 | 164 | 1 | 149 |
| 2016 | 3 | 182 | 0 | 135 |
| 2017 | 0 | — | 1 | 262 |
| 2018 | 0 | — | 1 | 878 |
| 2019 | 1 | — | 7 | 765 |
| 2020 | 1 | — | 0 | 959 |
| 2021 | 0 | — | 0 | 1,285 |
| 2022 | 0 | — | 1 | 1,334 |
| 2023 | 1 | — | 0 | 1,221 |
| 2024 | 1 | — | 0 | 1,896 |
| 2025 | 2 | — | 0 | 4,308 |
| 2026 | 1 | — | 1 (1) | — |
What is it indicated for?
The grantAdler Rhapsody Access Port and Catheter is indicated for any patient requiring reliable repeated access of the vascular system for delivery of medications, nutritional supplementation, fluids, blood. blood products or the sampling of blood.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043178 · printed Nov 6, 2026
Cite this page
510(k) Report. “K043178: Grantalder Rhapsody Access Port and Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K043178
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026