510(k) · Cleared
Recalled · Class II · 2018Nmi Port II Catheter
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 Aug 8, 2013 as substantially equivalent to K122767 (Navilyst Medical, Inc., 2013) and 1 other predicate after a 59-day review. Its family tree reaches back 11 generations to 2000. 2 of the 70 devices in its family, counting itself, have a Class I recall. 2 later devices descend from it. It has been recalled 2 times.
- Decided
- Aug 8, 2013
- Review
- 59 days
- Class
- Class II
- Product code
- LJT
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 11 generations to K001901 (2000). 67 ancestors in all, the oldest K830256 (1983). 2 later devices descend from it, 2 citing it directly. 2 of the 70 devices in this family, counting this one, have a Class I recall.
- Root · 11 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
- 7 generations between
- 3 generations backK071993 T-Port HP Infusion PortPfm Medical, Inc. · 2007
- 2 generations backK073210 Modification to: T-Port HP Infusion PortPfm Medical, Inc. · 2007
- 1 generation backK122767 Nmi PortNavilyst Medical, Inc. · 2013 · Recalled
- This deviceK131694 Nmi Port II CatheterNavilyst Medical, Inc. · 2013
- Descendant · cites it directly · 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 11 generations
- Root · 11 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
- 10 generations backK012902 Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly…C.R. Bard, Inc. · 2001
- 9 generations backK031129 Poly Per-Q-Cath Picc Catheters; Poly RadpiccC.R. Bard, Inc. · 2003
- 8 generations backK034019 Poly Per-Q-Cath Picc CathetersC.R. Bard, Inc. · 2004 · Recalled
- 7 generations backK050931 6 FR DL Powerpicc CatheterC.R. Bard, Inc. · 2005
- 6 generations backK051672 PowerpiccBard Access Systems, Inc. · 2005 · Recalled
- 5 generations backK060812 Powerport (TM)Implanted Titanium Port W/8 FR. Chronoflex…C.R. Bard, Inc. · 2006 · Recalled
- 4 generations backK070003 Power Injectable Implantable Infusion Port with Silicone Lumen…Medcomp · 2007 · Recalled
- 3 generations backK071993 T-Port HP Infusion PortPfm Medical, Inc. · 2007
- 2 generations backK073210 Modification to: T-Port HP Infusion PortPfm Medical, Inc. · 2007
- 1 generation backK122767 Nmi PortNavilyst Medical, Inc. · 2013 · Recalled
- This deviceK131694 Nmi Port II CatheterNavilyst Medical, Inc. · 2013
Class I recalls in this family
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K001901 | Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath Midline… | C.R. Bard, Inc. | 2000 | 2 |
| −10 | K012902 | Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly Per-Q-Cath… | C.R. Bard, Inc. | 2001 | — |
| −9 | K031129 | Poly Per-Q-Cath Picc Catheters; Poly Radpicc | C.R. Bard, Inc. | 2003 | — |
| −8 | K034019 | Poly Per-Q-Cath Picc Catheters | C.R. Bard, Inc. | 2004 | 1 |
| −7 | K050931 | 6 FR DL Powerpicc Catheter | C.R. Bard, Inc. | 2005 | — |
| −6 | K051672 | Powerpicc | Bard Access Systems, Inc. | 2005 | 1 |
| −5 | K060812 | Powerport (TM)Implanted Titanium Port W/8 FR. Chronoflex Catheter-Multiple | C.R. Bard, Inc. | 2006 | 1 |
| −4 | K070003 | Power Injectable Implantable Infusion Port with Silicone Lumen (Attachable and… | Medcomp | 2007 | 3 |
| −3 | K071993 | T-Port HP Infusion Port | Pfm Medical, Inc. | 2007 | — |
| −2 | K073210 | Modification to: T-Port HP Infusion Port | Pfm Medical, Inc. | 2007 | — |
| −1 | K122767 | Nmi Port | Navilyst Medical, Inc. | 2013 | 6 |
| 0 (this device) | K131694 | Nmi Port II Catheter | Navilyst Medical, Inc. | 2013 | — |
| +1 | 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 |
|---|---|---|
| 1983 | 1 | 0 |
| 1986 | 2 | 1 |
| 1987 | 2 | 0 |
| 1989 | 4 | 0 |
| 1991 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 4 | 1 |
| 2001 | 5 | 0 |
| 2002 | 1 | 0 |
| 2003 | 6 | 0 |
| 2004 | 5 | 0 |
| 2005 | 6 | 0 |
| 2006 | 4 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 3 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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.
2 devices in this family have a Class I recall. 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? (2)
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 |
|---|---|---|---|
| * | K122767 | Nmi PortSummary page 1…tion Panel: 2ICFR§880.5965, Class 11 General Hospital Premarket Notification: K 122767 1rade Name: NMI P1CC III Common/Usual name: Peripherally Inserte… | 2013 |
| * | K121089 | Nmi Picc IiiSummary page 1…ion Panel: 2ICFR§880.5970, Class 11 General Hospital Premarket Notification: K 121089 5-2 E. Device De… | 2012 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 24, 2018 | Class II | Z-0076-2019 | Unknown/Undetermined by firm | BioFlo Ports was partially manufactured with the incorrect sterile port assembly. The actual sterile port assembly used was, 8F SL Xcela Plus Titanium Valved Non-Filled, when it should have been, 8F SL BioFlo Plastic Valved Non-Filled |
| 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. |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K993691Arrowg +Ard Blue Plus Antimicrobial Multi-Lumen Central Venous CatheterArrow Intl., Inc. · 2000 · 5 generations back · ◆ in the 2000 ancestors bar of FIG. 11 Class I recall
- K862056[Central Venous][Multi-Lumen] Catheter W/Flex TipArrow Intl., Inc. · 1986 · 6 generations back · ◆ in the 1986 ancestors bar of FIG. 11 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 9 months on median.
- 30 of the 67 ancestors have a recall of any class; 2 have a Class I recall.
- Of its descendants, K190559 (AngioDynamics, Inc., 2020) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K122767.
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 Port 11 with and without PASV Valve Technology is 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 Port 11 is indicated for power injection of contrast media. The maximum recommended infusion rate is 5 mi/sec with a 19G or 20G non-coring power injectable needle or 2 mI/sec with a 220 non-coring power injectable needle.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131694 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131694: Nmi Port II Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131694
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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