510(k) · Cleared
Recalled · Class II · 2019Nmi Port
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Navilyst Medical, Inc. · LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
Cleared on Apr 30, 2013 as substantially equivalent to K030083 (Boston Scientific Corp, 2003) and 7 other predicates after a 232-day review. Its family tree reaches back 10 generations to 2000. 3 later devices descend from it. It has been recalled 6 times.
- Decided
- Apr 30, 2013
- Review
- 232 days
- Class
- Class II
- Product code
- LJT
- Recalls
- 6
- Predicates
- 8
Its longest line of descent runs back 10 generations to K001901 (2000). 31 ancestors in all, the oldest K863606 (1986). 3 later devices descend from it, 2 citing it directly.
- Root · 10 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
- 6 generations between
- 3 generations backK070003 Power Injectable Implantable Infusion Port with Silicone Lumen…Medcomp · 2007 · Recalled
- 2 generations backK071993 T-Port HP Infusion PortPfm Medical, Inc. · 2007
- 1 generation backK073210 Modification to: T-Port HP Infusion PortPfm Medical, Inc. · 2007
- This deviceK122767 Nmi PortNavilyst Medical, Inc. · 2013
- Descendant · cites it directly · 2 of its ownK131694 Nmi Port II CatheterNavilyst Medical, Inc. · 2013 · Recalled
- Descendant · 2 generations on · 0 of its ownK190559 SmartPort+ Implantable Ports, SmartPort Plastic Implantable PortsAngioDynamics, Inc. · 2020
- Descendant · cites it directly · 0 of its ownK153228 NMI Port, NMI Port IINavilyst Medical, Inc. · 2015
Show all 10 generations
- Root · 10 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
- 9 generations backK012902 Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly…C.R. Bard, Inc. · 2001
- 8 generations backK031129 Poly Per-Q-Cath Picc Catheters; Poly RadpiccC.R. Bard, Inc. · 2003
- 7 generations backK034019 Poly Per-Q-Cath Picc CathetersC.R. Bard, Inc. · 2004 · Recalled
- 6 generations backK050931 6 FR DL Powerpicc CatheterC.R. Bard, Inc. · 2005
- 5 generations backK051672 PowerpiccBard Access Systems, Inc. · 2005 · Recalled
- 4 generations backK060812 Powerport (TM)Implanted Titanium Port W/8 FR. Chronoflex…C.R. Bard, Inc. · 2006 · Recalled
- 3 generations backK070003 Power Injectable Implantable Infusion Port with Silicone Lumen…Medcomp · 2007 · Recalled
- 2 generations backK071993 T-Port HP Infusion PortPfm Medical, Inc. · 2007
- 1 generation backK073210 Modification to: T-Port HP Infusion PortPfm Medical, Inc. · 2007
- This deviceK122767 Nmi PortNavilyst Medical, Inc. · 2013
Most influential descendants
Showing 3 of 3 · See all- K131694Nmi Port II CatheterNavilyst Medical, Inc. · 2013 · cites it directly2descendants
- K190559SmartPort+ Implantable Ports, SmartPort Plastic Implantable PortsAngioDynamics, Inc. · 2020 · 2 generations on0descendants
- K153228NMI Port, NMI Port IINavilyst Medical, Inc. · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K001901 | Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath Midline… | C.R. Bard, Inc. | 2000 | 2 |
| −9 | K012902 | Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly Per-Q-Cath… | C.R. Bard, Inc. | 2001 | — |
| −8 | K031129 | Poly Per-Q-Cath Picc Catheters; Poly Radpicc | C.R. Bard, Inc. | 2003 | — |
| −7 | K034019 | Poly Per-Q-Cath Picc Catheters | C.R. Bard, Inc. | 2004 | 1 |
| −6 | K050931 | 6 FR DL Powerpicc Catheter | C.R. Bard, Inc. | 2005 | — |
| −5 | K051672 | Powerpicc | Bard Access Systems, Inc. | 2005 | 1 |
| −4 | K060812 | Powerport (TM)Implanted Titanium Port W/8 FR. Chronoflex Catheter-Multiple | C.R. Bard, Inc. | 2006 | 1 |
| −3 | K070003 | Power Injectable Implantable Infusion Port with Silicone Lumen (Attachable and… | Medcomp | 2007 | 3 |
| −2 | K071993 | T-Port HP Infusion Port | Pfm Medical, Inc. | 2007 | — |
| −1 | K073210 | Modification to: T-Port HP Infusion Port | Pfm Medical, Inc. | 2007 | — |
| 0 (this device) | K122767 | Nmi Port | Navilyst Medical, Inc. | 2013 | — |
| +1 | K131694 | Nmi Port II Catheter | Navilyst Medical, Inc. | 2013 | 2 |
| +2 | K190559 | SmartPort+ Implantable Ports, SmartPort Plastic Implantable Ports | AngioDynamics, Inc. | 2020 | — |
| +1 | K153228 | NMI Port, NMI Port II | Navilyst Medical, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1987 | 2 | 0 |
| 1989 | 4 | 0 |
| 1991 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2003 | 5 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2020 | 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? (8)
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 |
|---|---|---|---|
| * | K030083 | Vaxcel with Pasv PortSummary page 1…Short and Long-Term Intravascular Catheter Classification Panel: 2I1CFR§880.5965. Class ILI Premarket Notification(s): K030083, K03 1844, K032008, K032375, K032600, K071993, K072481 and K07321 0… | 2003 |
| * | K031844 | Vaxcel with Pasv Port (Low Profile), Models 45-236 and 45-238Summary page 1…t and Long-Term Intravascular Catheter Classification Panel: 2I1CFR§880.5965. Class ILI Premarket Notification(s): K030083, K03 1844, K032008, K032375, K032600, K071993, K072481 and K07321 0… | 2003 |
| * | K032008 | Vaxcel with Pasv Port, Model 45-213Summary page 1…-Term Intravascular Catheter Classification Panel: 2I1CFR§880.5965. Class ILI Premarket Notification(s): K030083, K03 1844, K032008, K032375, K032600, K071993, K072481 and K07321 0… | 2003 |
| * | K032375 | Vaxcel Port, Models 45-336 and 45-338Summary page 1…ravascular Catheter Classification Panel: 2I1CFR§880.5965. Class ILI Premarket Notification(s): K030083, K03 1844, K032008, K032375, K032600, K071993, K072481 and K07321 0… | 2003 |
| * | K032600 | Vaxcel Port, Model 45-333 and Vaxcel W/Pasv Port, Model 45-233Summary page 1…2I1CFR§880.5965. Class ILI Premarket Notification(s): K030083, K03 1844, K032008, K032375, K032600, K071993, K072481 and K07321 0… | 2003 |
| * | K071993 | T-Port HP Infusion PortSummary page 1…2I1CFR§880.5965. Class ILI Premarket Notification(s): K030083, K03 1844, K032008, K032375, K032600, K071993, K072481 and K07321 0 5-2 ===… | 2007 |
| * | K072481 | Jet Port Plus HP Catheter SystemSummary page 1…§880.5965. Class ILI Premarket Notification(s): K030083, K03 1844, K032008, K032375, K032600, K071993, K072481 and K07321 0 5-2 === Page 2 =… | 2008 |
| * | K073210 | Modification to: T-Port HP Infusion PortSummary page 1…lass ILI Premarket Notification(s): K030083, K03 1844, K032008, K032375, K032600, K071993, K072481 and K07321 0 5-2 E. Device… | 2007 |
What descends from it? (3)
2 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 18, 2019 | Class II | Z-0505-2020 | Under Investigation by firm | Snap lock connectors provided within implantable port kits may not meet dimensional specifications, and the catheter cannot be inserted into the snap lock connector prior to connection to the port chamber, resulting in a delay to the… |
| Sep 18, 2019 | Class II | Z-0501-2020 | Under Investigation by firm | Snap lock connectors provided within implantable port kits may not meet dimensional specifications, and the catheter cannot be inserted into the snap lock connector prior to connection to the port chamber, resulting in a delay to the… |
| Sep 18, 2019 | Class II | Z-0502-2020 | Under Investigation by firm | Snap lock connectors provided within implantable port kits may not meet dimensional specifications, and the catheter cannot be inserted into the snap lock connector prior to connection to the port chamber, resulting in a delay to the… |
| Sep 18, 2019 | Class II | Z-0504-2020 | Under Investigation by firm | Snap lock connectors provided within implantable port kits may not meet dimensional specifications, and the catheter cannot be inserted into the snap lock connector prior to connection to the port chamber, resulting in a delay to the… |
| Sep 18, 2019 | Class II | Z-0503-2020 | Under Investigation by firm | Snap lock connectors provided within implantable port kits may not meet dimensional specifications, and the catheter cannot be inserted into the snap lock connector prior to connection to the port chamber, resulting in a delay to the… |
| Nov 25, 2013 | Class II | Z-0826-2014 | Device Design | Navilyst Medical has recalled a Port Kit with Access Infusion Set due to a possible breach of sterilization barrier. |
The 5 latest of 6 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 5 companies; a new generation was cleared every 10 months on median.
- 18 of the 31 ancestors have a recall of any class.
- Of its descendants, K131694 (Navilyst Medical, Inc., 2013) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K030083.
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. 2013, this device’s year, is highlighted.
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 NMI Ports with and without PASV Valve Technology are indicated for patients who require long-term access to the central venous system for administration of fluids including but not limited to hydration fluids, chemotherapy, analgesics, nutritional therapy and blood products. The device is also indicated for blood specimen withdrawal.
When used with a power injectable needle, the NMI Ports are indicated for power injection of contrast media. The maximum recommended infusion rate is 5 ml/sec with a 19G or 20G non-coring power injectable needle or 2 ml/sec with a 22G non-coring power injectable needle.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122767 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122767: Nmi Port.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122767
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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