510(k) · Cleared
ClearedTidalPort-AP Implantable Apheresis Vascular Access Port
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Norfolk Medical Products, Inc. · PTD Subcutaneous Implanted Apheresis Port
Cleared on Aug 20, 2020 as substantially equivalent to K163001 (C.R. Bard, Inc., 2017) and 1 other predicate after a 363-day review. Its family tree reaches back 13 generations to 2000.
- Decided
- Aug 20, 2020
- Review
- 363 days
- Class
- Class II
- Product code
- PTD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 13 generations to K001901 (2000). 64 ancestors in all, the oldest K830000 (1983). No later device cites it as a predicate yet.
- Root · 13 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
- 9 generations between
- 3 generations backK102385 Norfolk Medical Norport Family of PortsNorfolk Medical Products, Inc. · 2011
- 2 generations backK111101 Norport CT-PC, Lucent Non-Coring Needel Infusion SetNorfolk Medical · 2011
- 1 generation backK112713 Norfolk Medical-Sportport-Family of PortsNorfolk Medical Products, Inc. · 2011
- This deviceK192291 TidalPort-AP Implantable Apheresis Vascular Access PortNorfolk Medical Products, Inc. · 2020
Show all 13 generations
- Root · 13 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
- 12 generations backK012902 Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly…C.R. Bard, Inc. · 2001
- 11 generations backK031129 Poly Per-Q-Cath Picc Catheters; Poly RadpiccC.R. Bard, Inc. · 2003
- 10 generations backK034019 Poly Per-Q-Cath Picc CathetersC.R. Bard, Inc. · 2004 · Recalled
- 9 generations backK050931 6 FR DL Powerpicc CatheterC.R. Bard, Inc. · 2005
- 8 generations backK051672 PowerpiccBard Access Systems, Inc. · 2005 · Recalled
- 7 generations backK060812 Powerport (TM)Implanted Titanium Port W/8 FR. Chronoflex…C.R. Bard, Inc. · 2006 · Recalled
- 6 generations backK062414 Vortex CT Port Access System and Lifeguard Safety Infusion SetRita Medical Systems, Inc. · 2007 · Recalled
- 5 generations backK072375 Smartport CT MP Port Access System and Lifeguard CT Safety Infusion…AngioDynamics, Inc. · 2007
- 4 generations backK081472 Smartport CT Vortex; LP Titanium, Single Plastic, Single Titanium…AngioDynamics, Inc. · 2008 · Recalled
- 3 generations backK102385 Norfolk Medical Norport Family of PortsNorfolk Medical Products, Inc. · 2011
- 2 generations backK111101 Norport CT-PC, Lucent Non-Coring Needel Infusion SetNorfolk Medical · 2011
- 1 generation backK112713 Norfolk Medical-Sportport-Family of PortsNorfolk Medical Products, Inc. · 2011
- This deviceK192291 TidalPort-AP Implantable Apheresis Vascular Access PortNorfolk Medical Products, Inc. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K001901 | Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath Midline… | C.R. Bard, Inc. | 2000 | 2 |
| −12 | K012902 | Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly Per-Q-Cath… | C.R. Bard, Inc. | 2001 | — |
| −11 | K031129 | Poly Per-Q-Cath Picc Catheters; Poly Radpicc | C.R. Bard, Inc. | 2003 | — |
| −10 | K034019 | Poly Per-Q-Cath Picc Catheters | C.R. Bard, Inc. | 2004 | 1 |
| −9 | K050931 | 6 FR DL Powerpicc Catheter | C.R. Bard, Inc. | 2005 | — |
| −8 | K051672 | Powerpicc | Bard Access Systems, Inc. | 2005 | 1 |
| −7 | K060812 | Powerport (TM)Implanted Titanium Port W/8 FR. Chronoflex Catheter-Multiple | C.R. Bard, Inc. | 2006 | 1 |
| −6 | K062414 | Vortex CT Port Access System and Lifeguard Safety Infusion Set | Rita Medical Systems, Inc. | 2007 | 2 |
| −5 | K072375 | Smartport CT MP Port Access System and Lifeguard CT Safety Infusion Set | AngioDynamics, Inc. | 2007 | — |
| −4 | K081472 | Smartport CT Vortex; LP Titanium, Single Plastic, Single Titanium, Triumph Low… | AngioDynamics, Inc. | 2008 | 1 |
| −3 | K102385 | Norfolk Medical Norport Family of Ports | Norfolk Medical Products, Inc. | 2011 | — |
| −2 | K111101 | Norport CT-PC, Lucent Non-Coring Needel Infusion Set | Norfolk Medical | 2011 | — |
| −1 | K112713 | Norfolk Medical-Sportport-Family of Ports | Norfolk Medical Products, Inc. | 2011 | — |
| 0 (this device) | K192291 | TidalPort-AP Implantable Apheresis Vascular Access Port | Norfolk Medical Products, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1984 | 1 | 0 |
| 1986 | 2 | 0 |
| 1987 | 5 | 0 |
| 1988 | 1 | 0 |
| 1989 | 4 | 0 |
| 1991 | 2 | 0 |
| 1992 | 1 | 0 |
| 1994 | 4 | 0 |
| 1995 | 2 | 0 |
| 1996 | 2 | 0 |
| 2000 | 3 | 0 |
| 2001 | 3 | 0 |
| 2002 | 2 | 0 |
| 2003 | 4 | 0 |
| 2004 | 3 | 0 |
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2007 | 3 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2017 | 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 PTD? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K163001 | PowerFlow Apheresis I.V. PortSummary page 4…erFlow™ Implantable Apheresis IV Port with 9.6 Fr. ChronoFlex Catheter Premarket Notification: K163001 Product Code: PTD 7350 N. Ridgeway Ÿ Skokie, I… | 2017 |
| * | K112713 | Norfolk Medical-Sportport-Family of PortsSummary page 5…l SportPort™ (now TidalPortt™) Family of Vascular Access Ports Premarket Notification: K112713 Product Code: LJT 5.4 Device Description The TidalPort-AP™ has one port size (… | 2011 |
What descends from it?
No later submission names this one as a predicate yet.
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 20 years and passes through 6 companies; a new generation was cleared every 9 months on median.
- 28 of the 64 ancestors have a recall of any class.
- 1 other device also cites its predicate K163001.
How does its category compare?
All PTD devicesPTD Subcutaneous Implanted Apheresis Port: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · PTD
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · PTD
Too few PTD 510(k)s in any year since 2007 to give a median.
Recalls per year · PTD
No recall names PTD since 2007.
Adverse event reports per year · PTD
26in 2025
MAUDE reports naming product code PTD, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 4 |
| 2018 | 0 | — | 0 | 15 |
| 2019 | 1 | — | 0 | 35 |
| 2020 | 1 | — | 0 | 18 |
| 2021 | 0 | — | 0 | 15 |
| 2022 | 0 | — | 0 | 11 |
| 2023 | 0 | — | 0 | 25 |
| 2024 | 0 | — | 0 | 22 |
| 2025 | 0 | — | 0 | 26 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The TidalPort-AP™ Implantable Apheresis Vascular Access Port is indicated for therapies requiring repeated access to the vascular system. The port system can be used for long-term therapeutic apheresis, withdrawal of blood, and infusion of medications, I.V. fluids, parenteral nutrition solutions, blood, and blood products.
The TidalPort-AP™ Implantable Apheresis Vascular Access Port is indicated for power injection of contrast media. For power injection of contrast media, the maximium recommended infusion rate is 5 mL/s.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192291 · printed Nov 5, 2026
Cite this page
510(k) Report. “K192291: TidalPort-AP Implantable Apheresis Vascular Access Port.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K192291
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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