510(k) · Cleared
ClearedT3
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medcomp · NIE Catheter, Hemodialysis, Triple Lumen, Non-Implanted
Cleared on Jun 11, 2013 as substantially equivalent to K033570 (Medcomp, 2004) and 8 other predicates after a 232-day review. Its family tree reaches back 9 generations to 2000. 4 of the 57 devices in its family, counting itself, have a Class I recall. 2 later devices descend from it.
- Decided
- Jun 11, 2013
- Review
- 232 days
- Class
- Class II
- Product code
- NIE
- Recalls
- None
- Predicates
- 10
Its longest line of descent runs back 9 generations to K001901 (2000). 54 ancestors in all, the oldest K830256 (1983). 2 later devices descend from it, 1 citing it directly. 4 of the 57 devices in this family, counting this one, have a Class I recall.
- Root · 9 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
- 5 generations between
- 3 generations backK051991 Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and…C.R. Bard, Inc. · 2005
- 2 generations backK070996 4 FR Single Lumen (SL) Powerpicc CatheterC.R. Bard, Inc. · 2007
- 1 generation backK091953 Pro-PiccMedcomp · 2009
- This deviceK123292 T3Medcomp · 2013
- Descendant · cites it directly · 1 of its ownK183219 Trio-CT Triple Lumen CatheterMedical Components, Inc. (dba MedComp) · 2019
- Descendant · 2 generations on · 0 of its ownK232945 Trio-CT® Triple Lumen Catheter w/ Curved ExtensionsMedical Components, Inc. (dba MedComp) · 2023
Show all 9 generations
- Root · 9 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
- 8 generations backK012902 Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly…C.R. Bard, Inc. · 2001
- 7 generations backK031129 Poly Per-Q-Cath Picc Catheters; Poly RadpiccC.R. Bard, Inc. · 2003
- 6 generations backK033389 Powerpicc Catheters, Models 3175155, 3175135C.R. Bard, Inc. · 2004 · Recalled
- 5 generations backK050185 Powerhohn and Powerline CathetersC.R. Bard, Inc. · 2005
- 4 generations backK051417 6 FR FL Powerhohn and Powerline CatheterC.R. Bard, Inc. · 2005 · Recalled
- 3 generations backK051991 Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and…C.R. Bard, Inc. · 2005
- 2 generations backK070996 4 FR Single Lumen (SL) Powerpicc CatheterC.R. Bard, Inc. · 2007
- 1 generation backK091953 Pro-PiccMedcomp · 2009
- This deviceK123292 T3Medcomp · 2013
Class I recalls in this family
- K102605 Mahurkar Triple Lumen Dialysis Catheterdirect predicate · 2010
- K020089 Mahurkar Triple Lumen Catheter, 12 FR2 generations back · 2002
- K993691 Arrowg +Ard Blue Plus Antimicrobial Multi-Lumen…4 generations back · 2000
- K862056 [Central Venous][Multi-Lumen] Catheter W/Flex Tip5 generations back · 1986
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 |
|---|---|---|---|---|---|
| −9 | K001901 | Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath Midline… | C.R. Bard, Inc. | 2000 | 2 |
| −8 | K012902 | Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly Per-Q-Cath… | C.R. Bard, Inc. | 2001 | — |
| −7 | K031129 | Poly Per-Q-Cath Picc Catheters; Poly Radpicc | C.R. Bard, Inc. | 2003 | — |
| −6 | K033389 | Powerpicc Catheters, Models 3175155, 3175135 | C.R. Bard, Inc. | 2004 | 1 |
| −5 | K050185 | Powerhohn and Powerline Catheters | C.R. Bard, Inc. | 2005 | — |
| −4 | K051417 | 6 FR FL Powerhohn and Powerline Catheter | C.R. Bard, Inc. | 2005 | 1 |
| −3 | K051991 | Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and Power Line | C.R. Bard, Inc. | 2005 | — |
| −2 | K070996 | 4 FR Single Lumen (SL) Powerpicc Catheter | C.R. Bard, Inc. | 2007 | — |
| −1 | K091953 | Pro-Picc | Medcomp | 2009 | — |
| 0 (this device) | K123292 | T3 | Medcomp | 2013 | — |
| +1 | K183219 | Trio-CT Triple Lumen Catheter | Medical Components, Inc. (dba MedComp) | 2019 | — |
| +2 | K232945 | Trio-CT® Triple Lumen Catheter w/ Curved Extensions | Medical Components, Inc. (dba MedComp) | 2023 | — |
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 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 3 | 0 |
| 1999 | 2 | 0 |
| 2000 | 3 | 1 |
| 2001 | 5 | 0 |
| 2002 | 3 | 1 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 5 | 0 |
| 2006 | 3 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 1 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2023 | 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.
4 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 NIE device
- #1 K232945 Trio-CT® Triple Lumen Catheter w/ Curved…score 9.4 · 11 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (10)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K033570 | Medcomp T-3Summary page 1…76.5540 Gastroenterology and Urology 11, 78 NIE e 033345 Pre-Eine-ET<Power-Injectable-GV.C: concurrence-date-March#17:-2006 - Class-I1+ Predicate Devices: Primary: K 033570, T3 concurrence date September 16, 2004. Class IT CFR §876.5540 K083675, Power-Trialysis™ Short Term Dialysis Catheter, concurre… | 2004 |
| * | K083675 | Power-Trialysis Triple Lumen Acute Dialysis CatheterSummary page 1…wer-Injectable-GV.C: concurrence-date-March#17:-2006 - Class-I1+ Predicate Devices: Primary: K 033570, T3 concurrence date September 16, 2004. Class IT CFR §876.5540 K083675, Power-Trialysis™ Short Term Dialysis Catheter, concurrence date March 19, 2009. Class [ CFR §876.5540 K1026¢35, MAHURKART™ Tri… | 2009 |
| * | K102605 | Mahurkar Triple Lumen Dialysis Catheter Our OCR of the scanned summary read K102635, FDA’s number for Apolonia Laser Implant System (Csm Implant Co., Ltd.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “MAHURKART™ Triple Lumen Catheter”. | 2010 |
| * | K121848 | Split Cath Iii 24CM Split Cath Iii 24CM Split Cath Iii 32CM Cath Iii 36CM Split Cath Iii…Summary page 1…ce date March 19, 2009. Class [ CFR §876.5540 K1026¢35, MAHURKART™ Triple Lumen Catheter, concurrence date December 22, 2000. Class 1I CFR §876.5540 ' Secondary: ‘ ) K 121848, SCII Chronoflex, concurrence date September 21, 2012, Class III CFR §876.5340 K.091933, Pro-Picc CT, concurrence date September… | 2012 |
| * | K091953 | Pro-Picc Our OCR of the scanned summary read K091933, FDA’s number for Electro-Acupuncture: Aculife/Model Idoc-01 (Inno-Health Technology, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Pro-Picc CT”. | 2009 |
| * | K020465 | Medcomp Ash Split-Cath II Our OCR of the scanned summary read K020463, FDA’s number for Depilase Yag Lase Plus Laser System (Depilase Group, Ltd.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Ash Split Cath II”. | 2002 |
| * | K981125 | Medcomp Tesio Catheter, Models MBR-6, MBL-6, MBS-6 Our OCR of the scanned summary read K981123, FDA’s number for UREA (Trace Scientific, Ltd.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Silicone Tesio”. | 1999 |
| * | K091586 | Vascu-Picc and Midline Catheters, Single, Double and Triple LumenSummary page 1…020463, Ash Split Cath I1, concurrence date May 22, 2002. Class IT1 CFR §876.5540 K981123, Silicone Tesio, concurrence date February 26, 1999. Class IIT CFR §876.5540 K 091586, Vascu-Pice and Midline Catheters, concurrence date July 23, 2009. Class 11 CFR §876.5970 . K070003, Power Injectable Implantabl… | 2009 |
| * | K070003 | Power Injectable Implantable Infusion Port with Silicone Lumen (Attachable and…Summary page 1…Tesio, concurrence date February 26, 1999. Class IIT CFR §876.5540 K 091586, Vascu-Pice and Midline Catheters, concurrence date July 23, 2009. Class 11 CFR §876.5970 . K070003, Power Injectable Implantable Port concurrence date May 15, 2007. Class II CFR §876.5965 K (72309, Pro- Pice CT, concurrence dat… | 2007 |
| Kept off the family tree | K072309 | FDA’s K072309 is Microlux/Blu Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2007 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K183219 | Trio-CT Triple Lumen Catheter | 2019 | 1 |
Has anything in its family been recalled? (4 Class I)
No FDA recall names this device.
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.
- K102605Mahurkar Triple Lumen Dialysis CatheterCovidien, LLC, Formerly Registered AS Tyco Healthca · 2010 · Direct predicate · ◆ in the 2010 ancestors bar of FIG. 125 Class I recalls
- K020089Mahurkar Triple Lumen Catheter, 12 FRThe Kendall Company · 2002 · 2 generations back · ◆ in the 2002 ancestors bar of FIG. 125 Class I recalls
- K993691Arrowg +Ard Blue Plus Antimicrobial Multi-Lumen Central Venous CatheterArrow Intl., Inc. · 2000 · 4 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 · 5 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 2 companies; a new generation was cleared every 1.2 years on median.
- 25 of the 54 ancestors have a recall of any class; 4 have a Class I recall.
- Of its descendants, K183219 (Medical Components, Inc. (dba MedComp), 2019) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K033570.
How does its category compare?
All NIE devicesNIE Catheter, Hemodialysis, Triple Lumen, Non-Implanted: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · NIE
2in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · NIE
Too few NIE 510(k)s in any year since 2007 to give a median.
Recalls per year · NIE
6in 2025
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · NIE
72in 2025
MAUDE reports naming product code NIE, 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 | 2 |
| 2009 | 1 | — | 0 | 3 |
| 2010 | 1 | — | 0 | 5 |
| 2011 | 0 | — | 0 | 12 |
| 2012 | 0 | — | 0 | 9 |
| 2013 | 1 | — | 0 | 7 |
| 2014 | 1 | — | 0 | 13 |
| 2015 | 2 | — | 0 | 7 |
| 2016 | 0 | — | 0 | 13 |
| 2017 | 0 | — | 0 | 38 |
| 2018 | 1 | — | 0 | 88 |
| 2019 | 1 | — | 1 | 61 |
| 2020 | 0 | — | 0 | 51 |
| 2021 | 0 | — | 0 | 61 |
| 2022 | 0 | — | 1 (1) | 119 |
| 2023 | 2 | — | 0 | 103 |
| 2024 | 0 | — | 0 | 125 |
| 2025 | 0 | — | 6 | 72 |
| 2026 | 0 | — | 3 (1) | — |
What is it indicated for?
The Medcomp® T3™ catheter is a triple lumen catheter indicated for use in attaining short-term vascular access for hemodialysis, apheresis. The third internal lumen is intended for infusion, power injection of contrast media and central venous pressure monitoring.
The catheter is intended to be inserted in the jugular, femoral or subclavian vein as required. The maximum recommended infusion rate is 5ml/sec for power injection of contrast media.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K123292 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123292: T3.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123292
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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