510(k) Report

510(k) · Cleared

Cleared

Invisiport

K110407510(k) TraditionalCleared Oct 13, 2011241-day reviewClass II21 CFR 880.5965

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Stealth Therapeutics, Incorporated · LJT Port & Catheter, Implanted, Subcutaneous, Intravascular

Cleared on Oct 13, 2011 as substantially equivalent to K043178 (Grantadler Corportation, 2006) and 3 other predicates after a 241-day review. Its family tree reaches back 7 generations to 2000. 1 later device descends from it.

Decided
Oct 13, 2011
Review
241 days
Class
Class II
Product code
LJT
Recalls
None
Predicates
4

Its longest line of descent runs back 7 generations to K001901 (2000). 24 ancestors in all, the oldest K863606 (1986). 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2006: 2 other ancestors1995: 2 other ancestors2005: 2 other ancestors2004: 2 other ancestors2001: 1 other ancestor1987: 1 other ancestor2000: 1 other ancestor1986: 1 other ancestor1991: 1 other ancestor1989: 4 other ancestors2015: 1 descendant clearedK001901 · Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath Midline Catheter, Model 3134135 · C.R. Bard, Inc. · 2000 · recalledK012902 · Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly Per-Q-Cath Dual Lumen Picc Catheter, Model 3246100 · C.R. Bard, Inc. · 2001K031129 · Poly Per-Q-Cath Picc Catheters; Poly Radpicc · C.R. Bard, Inc. · 2003K034019 · Poly Per-Q-Cath Picc Catheters · C.R. Bard, Inc. · 2004 · recalledK050931 · 6 FR DL Powerpicc Catheter · C.R. Bard, Inc. · 2005K051672 · Powerpicc · Bard Access Systems, Inc. · 2005 · recalledK060812 · Powerport (TM)Implanted Titanium Port W/8 FR. Chronoflex Catheter-Multiple · C.R. Bard, Inc. · 2006 · recalled1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors2 generations back: 3 other ancestors3 generations back: 3 other ancestors4 generations back: 3 other ancestors5 generations back: 5 other ancestors 1 generation forward: 1 descendant K060812 · Powerport (TM)Implanted Titanium Port W/8 FR. Chronoflex Catheter-Multiple · C.R. Bard, Inc. · 2006 · recalledK051672 · Powerpicc · Bard Access Systems, Inc. · 2005 · recalledK050931 · 6 FR DL Powerpicc Catheter · C.R. Bard, Inc. · 2005K034019 · Poly Per-Q-Cath Picc Catheters · C.R. Bard, Inc. · 2004 · recalledK031129 · Poly Per-Q-Cath Picc Catheters; Poly Radpicc · C.R. Bard, Inc. · 2003K012902 · Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly Per-Q-Cath Dual Lumen Picc Catheter, Model 3246100 · C.R. Bard, Inc. · 2001K001901 · Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath Midline Catheter, Model 3134135 · C.R. Bard, Inc. · 2000 · recalled−50
  1. Root · 7 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
  2. 6 generations backK012902 Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly…C.R. Bard, Inc. · 2001
  3. 5 generations backK031129 Poly Per-Q-Cath Picc Catheters; Poly RadpiccC.R. Bard, Inc. · 2003
  4. 4 generations backK034019 Poly Per-Q-Cath Picc CathetersC.R. Bard, Inc. · 2004 · Recalled
  5. 3 generations backK050931 6 FR DL Powerpicc CatheterC.R. Bard, Inc. · 2005
  6. 2 generations backK051672 PowerpiccBard Access Systems, Inc. · 2005 · Recalled
  7. 1 generation backK060812 Powerport (TM)Implanted Titanium Port W/8 FR. Chronoflex…C.R. Bard, Inc. · 2006 · Recalled
  8. This deviceK110407 InvisiportStealth Therapeutics, Incorporated · 2011
  9. Descendant · cites it directly · 0 of its ownK141146 InvisiportStealth Therapeutics, Incorporated · 2015

Most influential descendants

Showing 1 of 1 · See all
  • K141146InvisiportStealth Therapeutics, Incorporated · 2015 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−7K001901Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath Midline…C.R. Bard, Inc.20002
−6K012902Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly Per-Q-Cath…C.R. Bard, Inc.2001—
−5K031129Poly Per-Q-Cath Picc Catheters; Poly RadpiccC.R. Bard, Inc.2003—
−4K034019Poly Per-Q-Cath Picc CathetersC.R. Bard, Inc.20041
−3K0509316 FR DL Powerpicc CatheterC.R. Bard, Inc.2005—
−2K051672PowerpiccBard Access Systems, Inc.20051
−1K060812Powerport (TM)Implanted Titanium Port W/8 FR. Chronoflex Catheter-MultipleC.R. Bard, Inc.20061
0 (this device)K110407InvisiportStealth Therapeutics, Incorporated2011—
+1K141146InvisiportStealth Therapeutics, Incorporated2015—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198610
198710
198940
199110
199520
200010
200110
200420
200520
200620

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201510
FIG. 1 — Lineage of K110407, 2000–2015Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K251253 PowerPort™ isp Implantable Port; PowerPort™…score 14.9 · 9 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (4)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K043178Grantalder Rhapsody Access Port and Catheter
Summary page 1
…Implantable Infusion Port Classification Name: Subcewaneous, Implanted, Intravascular Infusion Port and Catheter 21 CFR 880.39635, Product Code LIT Predicate Devices: K043178, Rhapsody Access Port mantfaciured by GrantAdler Corporation KO60812, PowerPort™ Implantable Titanium Port manutactured by C.R.…
Grantadler Corportation2006—
*K060812Powerport (TM)Implanted Titanium Port W/8 FR. Chronoflex Catheter-Multiple
Summary page 2
…K(043178, Port CATH Feature (Under Review) K9345l8 K(082126 K060812 K(060036 Comment Indications The Invisziportl The Penflort is a Th…
C.R. Bard, Inc.20061
*K060036Port-a-Cath, Port-a-Cath II, Proport and P.a.S. Port Implantable Venous Access Systems…
Summary page 1
…Predicate Devices: K043178, Rhapsody Access Port mantfaciured by GrantAdler Corporation KO60812, PowerPort™ Implantable Titanium Port manutactured by C.R. Bard, Inc. : K060036, PORT-A-CATH manufactured by Smiths Medical K934518, PertPort manufactured by Strato Medical Corp. 5.1 Product Description The…
Smiths Medical MD, Inc.2006—
*K934518Strato Medical Infuse-a-Port/Infuse-a-Kit Periport Peripheral Access System
Summary page 1
…faciured by GrantAdler Corporation KO60812, PowerPort™ Implantable Titanium Port manutactured by C.R. Bard, Inc. : K060036, PORT-A-CATH manufactured by Smiths Medical K934518, PertPort manufactured by Strato Medical Corp. 5.1 Product Description The Invisiport™ consists of an injection port made from…
Strato Medical Corp.1995—

Also cleared against K043178: 2 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K141146InvisiportStealth Therapeutics, Incorporated20150

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?

  • The line of descent spans 11 years and passes through 3 companies; a new generation was cleared every 12 months on median.
  • 12 of the 24 ancestors have a recall of any class.
  • Of its descendants, K141146 (Stealth Therapeutics, Incorporated, 2015) has gone furthest, with 0 descendants of its own.
  • 2 other devices also cite its predicate K043178.

How does its category compare?

All LJT devices

LJT Port & Catheter, Implanted, Subcutaneous, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.

FDA decisions per year · LJT

2in 2025

2007: 112008: 72009: 22010: 22011: 52012: 22013: 72014: 22015: 42016: 32019: 12020: 12023: 12024: 12025: 22026 (partial year): 1
2007high 11 (2007) · low 0 (2017)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LJT

182in 2016

2007: 85 days median2008: 119 days median2011: 144 days median2013: 150 days median2015: 164 days median2016: 182 days median
2007high 182 (2016) · low 85 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LJT

1in 2022

2007: 12008: 22009: 22010: 192011: 12012: 22015: 12017: 12018: 12019: 72022: 12026 (partial year): 1, 1 Class I
2007high 19 (2010) · low 0 (2013)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · LJT

4,308in 2025

2007: 2082008: 1612009: 1722010: 2072011: 2022012: 1532013: 1412014: 1432015: 1492016: 1352017: 2622018: 8782019: 7652020: 9592021: 1,2852022: 1,3342023: 1,2212024: 1,8962025: 4,308
2007high 4,308 (2025) · low 135 (2016)2025

MAUDE reports naming product code LJT, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200711851208
200871192161
20092—2172
20102—19207
201151441202
20122—2153
201371500141
20142—0143
201541641149
201631820135
20170—1262
20180—1878
20191—7765
20201—0959
20210—01,285
20220—11,334
20231—01,221
20241—01,896
20252—04,308
20261—1 (1)—

What is it indicated for?

The Invisiport™ is indicated for any patient requiring repeated access of the vascular system for delivery of medications, nutritional supplementation, fluids, blood, blood products, or the sampling of blood, or for power injection of contrast media when used with a power-injectable Huber needle or infusion set.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K043178

2 other devices cite the same predicate.

  • K082126Rhapsody MriGrantadler Corporation · 2008
  • K081889Rhapsody CTGrantadler Corporation · 2008

More from Stealth Therapeutics, Incorporated

2 FDA decisions under this applicant name. See the company

  • K141146InvisiportStealth Therapeutics, Incorporated · 2015

Recent decisions in LJT

The LJT category page

  • K260916FLEXI-PORT™ Power Injectable Implantable PortPortal Access, Inc. · 2026
  • K252478Vaccess™ CT Low-Profile Power-Injectable Implantable Port; Vaccess™ CT Power-Injectable Implantable Port…Bard Access Systems, Inc. · 2025
  • K251253PowerPort™ isp Implantable Port; PowerPort™ Slim Implantable Port; PowerPort™ M.R.I. ™ Implantable Port…Bard Access Systems, Inc. · 2025
  • K242328PowerPort™ ClearVUE™ Slim Implantable Ports and PowerPort™ ClearVUE™ Slim Implantable PortsBard Access Systems, Inc. · 2024
  • K232737PowerPort™ ClearVUE™ Slim ECG Enabled Implantable Port; PowerPort™ ClearVUE™ isp ECG Enabled Implantable…Bard Peripheral Vascular, Inc. · 2023

https://510kreport.com/device/K110407 · printed Nov 6, 2026

Cite this page

510(k) Report. “K110407: Invisiport.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110407

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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