510(k) · Cleared
Recalled · Class II · 2019Hemo-Cath Silicone Double Lumen Cath SL28C & SL40C
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medical Components, Inc. · LFJ Catheter, Subclavian
Cleared on Jun 13, 1989 after a 41-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it. It has been recalled 5 times.
- Decided
- Jun 13, 1989
- Review
- 41 days
- Class
- Class II
- Product code
- LFJ
- Recalls
- 5
- Predicates
- 0
5 later devices descend from it, 2 citing it directly.
- This deviceK893439 Hemo-Cath Silicone Double Lumen Cath SL28C & SL40CMedical Components, Inc. · 1989
- Descendant · cites it directly · 3 of its ownK113487 Hemo-Cath 10F, Hemo-Cath 12.5FMedical Components, Inc. · 2012
- Descendant · 2 generations on · 1 of its ownK130851 Cascade Hemodialysis/Apheresis CatheterHealth Line International Corporation · 2014
- Descendant · 3 generations on · 0 of its ownK241581 Hemodialysis CatheterHaolang Medical USA Corporation · 2025
- Descendant · 2 generations on · 0 of its ownK121383 PS X Series (Basic Components and Catheter), PD X Series (Catheter…Medical Components, Inc. · 2012
- Descendant · cites it directly · 0 of its ownK952660 Braun Hemodialysis CatheterB.Braun Medical, Inc. · 1996
Most influential descendants
Showing 5 of 5 · See all- K113487Hemo-Cath 10F, Hemo-Cath 12.5FMedical Components, Inc. · 2012 · cites it directly3descendants
- K130851Cascade Hemodialysis/Apheresis CatheterHealth Line International Corporation · 2014 · 2 generations on1descendant
- K241581Hemodialysis CatheterHaolang Medical USA Corporation · 2025 · 3 generations on0descendants
- K121383PS X Series (Basic Components and Catheter), PD X Series (Catheter with All Components)Medical Components, Inc. · 2012 · 2 generations on0descendants
- K952660Braun Hemodialysis CatheterB.Braun Medical, Inc. · 1996 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K893439 | Hemo-Cath Silicone Double Lumen Cath SL28C & SL40C | Medical Components, Inc. | 1989 | — |
| +1 | K113487 | Hemo-Cath 10F, Hemo-Cath 12.5F | Medical Components, Inc. | 2012 | — |
| +2 | K130851 | Cascade Hemodialysis/Apheresis Catheter | Health Line International Corporation | 2014 | — |
| +3 | K241581 | Hemodialysis Catheter | Haolang Medical USA Corporation | 2025 | — |
| +2 | K121383 | PS X Series (Basic Components and Catheter), PD X Series (Catheter with All… | Medical Components, Inc. | 2012 | — |
| +1 | K952660 | Braun Hemodialysis Catheter | B.Braun Medical, Inc. | 1996 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2012 | 2 | 0 |
| 2014 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LFJ? 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (5)
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 |
|---|---|---|---|---|
| Mar 13, 2019 | Class II | Z-1149-2019 | Finished device change control | Tray label indicates the kits are packaged with a 15F "valved" peelable introducer, but the kits contain a 15F "non-valved" peelable introducer. |
| Mar 13, 2019 | Class II | Z-2217-2019 | Labeling Change Control | Tray label indicates the kits are packaged with a 15F "valved" peelable introducer, but the kits contain a 15F "non-valved" peelable introducer. |
| Mar 13, 2019 | Class II | Z-2216-2019 | Labeling Change Control | Tray label indicates the kits are packaged with a 15F "valved" peelable introducer, but the kits contain a 15F "non-valved" peelable introducer. |
| Mar 13, 2019 | Class II | Z-2215-2019 | Labeling Change Control | Tray label indicates the kits are packaged with a 15F "valved" peelable introducer, but the kits contain a 15F "non-valved" peelable introducer. |
| Jan 21, 2015 | Class II | Z-1083-2015 | Process control | Drug products contained within the kits may have been rendered ineffective by a duplicate sterilization process. The kits include one or more of the following drugs: 5ml ampule of lidocaine, 3ml Chloraprep one-step, 10ml pre-filled saline… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K113487 (Medical Components, Inc., 2012) has gone furthest, with 3 descendants of its own.
How does its category compare?
All LFJ devicesLFJ Catheter, Subclavian: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LFJ
FDA has decided no LFJ device since 2007.
Median 510(k) review, days · LFJ
Too few LFJ 510(k)s in any year since 2007 to give a median.
Recalls per year · LFJ
1so far in 2026, the most since 2007
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · LFJ
28in 2025
MAUDE reports naming product code LFJ, 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 | 27 |
| 2008 | 0 | — | 0 | 22 |
| 2009 | 0 | — | 0 | 26 |
| 2010 | 0 | — | 0 | 45 |
| 2011 | 0 | — | 0 | 23 |
| 2012 | 0 | — | 0 | 34 |
| 2013 | 0 | — | 0 | 29 |
| 2014 | 0 | — | 0 | 23 |
| 2015 | 0 | — | 0 | 26 |
| 2016 | 0 | — | 0 | 34 |
| 2017 | 0 | — | 0 | 31 |
| 2018 | 0 | — | 0 | 31 |
| 2019 | 0 | — | 0 | 45 |
| 2020 | 0 | — | 0 | 43 |
| 2021 | 0 | — | 0 | 37 |
| 2022 | 0 | — | 0 | 34 |
| 2023 | 0 | — | 0 | 44 |
| 2024 | 0 | — | 0 | 48 |
| 2025 | 0 | — | 0 | 28 |
| 2026 | 0 | — | 1 (1) | — |
https://510kreport.com/device/K893439 · printed Nov 4, 2026
Cite this page
510(k) Report. “K893439: Hemo-Cath Silicone Double Lumen Cath SL28C & SL40C.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K893439
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026