510(k) · Decided
DecidedHemo-Cath 10F, Hemo-Cath 12.5F
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medical Components, Inc. · MSD Catheter, Hemodialysis, Implanted
Cleared on Mar 9, 2012 as substantially equivalent to K893439 (Medical Components, Inc., 1989) and 4 other predicates after a 107-day review. Its family tree reaches back 9 generations to 2000. 2 of the 33 devices in its family, counting itself, have a Class I recall. 3 later devices descend from it.
- Decided
- Mar 9, 2012
- Review
- 107 days
- Class
- Class II
- Product code
- MSD
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 9 generations to K001901 (2000). 29 ancestors in all, the oldest K830256 (1983). 3 later devices descend from it, 2 citing it directly. 2 of the 33 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 deviceK113487 Hemo-Cath 10F, Hemo-Cath 12.5FMedical Components, Inc. · 2012
- Descendant · cites it directly · 1 of its ownK130851 Cascade Hemodialysis/Apheresis CatheterHealth Line International Corporation · 2014
- Descendant · 2 generations on · 0 of its ownK241581 Hemodialysis CatheterHaolang Medical USA Corporation · 2025
- Descendant · cites it directly · 0 of its ownK121383 PS X Series (Basic Components and Catheter), PD X Series (Catheter…Medical Components, Inc. · 2012
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 deviceK113487 Hemo-Cath 10F, Hemo-Cath 12.5FMedical Components, Inc. · 2012
Class I recalls in this family
Most influential descendants
Showing 3 of 3 · See all- K130851Cascade Hemodialysis/Apheresis CatheterHealth Line International Corporation · 2014 · cites it directly1descendant
- K241581Hemodialysis CatheterHaolang Medical USA Corporation · 2025 · 2 generations on0descendants
- K121383PS X Series (Basic Components and Catheter), PD X Series (Catheter with All Components)Medical Components, Inc. · 2012 · cites it directly0descendants
View 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) | K113487 | Hemo-Cath 10F, Hemo-Cath 12.5F | Medical Components, Inc. | 2012 | — |
| +1 | K130851 | Cascade Hemodialysis/Apheresis Catheter | Health Line International Corporation | 2014 | — |
| +2 | K241581 | Hemodialysis Catheter | Haolang Medical USA Corporation | 2025 | — |
| +1 | K121383 | PS X Series (Basic Components and Catheter), PD X Series (Catheter with All… | Medical Components, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1986 | 1 | 1 |
| 1989 | 1 | 0 |
| 1996 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 1 |
| 2001 | 3 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 3 | 0 |
| 2006 | 2 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2025 | 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 MSD device
- #1 K241581 Hemodialysis Catheterscore 12.3 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
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 |
|---|---|---|---|
| * | K893439 | Hemo-Cath Silicone Double Lumen Cath SL28C & SL40CSummary page 1…s CFR Reference: -21 CFR 876.5540, ClasslIll Classification Panel: Gastroenterology / Urology Premarket Notification: K893439, 6oncurrence date June 13, 1989 K091953, concurrence date September 16, 2009… | 1989 |
| * | K091953 | Pro-PiccSummary page 1…sification Panel: Gastroenterology / Urology Premarket Notification: K893439, 6oncurrence date June 13, 1989 K091953, concurrence date September 16, 2009 K981 125, concurrence date February 26, 1999… | 2009 |
| * | K981125 | Medcomp Tesio Catheter, Models MBR-6, MBL-6, MBS-6Summary page 1…: K893439, 6oncurrence date June 13, 1989 K091953, concurrence date September 16, 2009 K981 125, concurrence date February 26, 1999 K(030270, concurrence date April 14, 2003… | 1999 |
| * | K030270 | 3F X 60 CM Single Lumen Silisone Vascu-Picc, 4F X 60CM Single Lumen Silicone Vascu-Picc…Summary page 1…K091953, concurrence date September 16, 2009 K981 125, concurrence date February 26, 1999 K(030270, concurrence date April 14, 2003 K(01 0306, concurrence date October 3, 2001 Performance… | 2003 |
| * | K010306 | Medcomp Excell Split Tip Catheter | 2001 |
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? (2 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.
- 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 12 years and passes through 3 companies; a new generation was cleared every 1.2 years on median.
- 14 of the 29 ancestors have a recall of any class; 2 have a Class I recall.
- Of its descendants, K130851 (Health Line International Corporation, 2014) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K893439.
How does its category compare?
All MSD devicesMSD Catheter, Hemodialysis, Implanted: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · MSD
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MSD
153in 2021
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MSD
1in 2013
Class I (4 since 2007) Class II/III not classified
Adverse event reports per year · MSD
1,054in 2025
MAUDE reports naming product code MSD, 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 | 7 | 92 | 0 | 118 |
| 2008 | 3 | 89 | 47 | 174 |
| 2009 | 6 | 81 | 49 | 173 |
| 2010 | 4 | 116 | 11 | 306 |
| 2011 | 7 | 70 | 24 | 268 |
| 2012 | 2 | — | 0 | 367 |
| 2013 | 5 | 105 | 1 | 363 |
| 2014 | 8 | 246 | 0 | 506 |
| 2015 | 1 | — | 0 | 550 |
| 2016 | 2 | — | 0 | 532 |
| 2017 | 2 | — | 0 | 484 |
| 2018 | 2 | — | 0 | 463 |
| 2019 | 1 | — | 0 | 645 |
| 2020 | 4 | 106 | 0 | 401 |
| 2021 | 4 | 153 | 0 | 523 |
| 2022 | 0 | — | 0 | 610 |
| 2023 | 0 | — | 0 | 542 |
| 2024 | 0 | — | 0 | 841 |
| 2025 | 1 | — | 0 | 1,054 |
| 2026 | 0 | — | 4 (4) | — |
What is it indicated for?
Medcomp's Hemo-Cath® silicone double lumen catheter can be utilitized for long term implantation as well as temporary access for hemddialysis, hemoperfusion, or apheresis therapy.
It may be inserted percutaneously and is primarily placed in the internal jugular vein of an adult patient.
Alternative insertion sites include subclavian vein as required.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113487 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113487: Hemo-Cath 10F, Hemo-Cath 12.5F.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113487
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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