510(k) · Cleared
Recalled · 2003Lifesite Hemodialysis Access System/Cannula Exchange, Model LHAS14120 & LHCEK0000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vasca, Inc. · MSD Catheter, Hemodialysis, Implanted
Cleared on Aug 24, 2000 as substantially equivalent to K821684 (Medical Components, Inc., 1982) and 1 other predicate after a 90-day review. Its family tree reaches back 1 generation to 1982. It has been recalled once.
- Decided
- Aug 24, 2000
- Review
- 90 days
- Class
- Class II
- Product code
- MSD
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 1 generation to K821684 (1982). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK821684 MCSCP8PS with 'Y' HubMedical Components, Inc. · 1982
- This deviceK001633 Lifesite Hemodialysis Access System/Cannula Exchange, Model…Vasca, Inc. · 2000
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K821684 | MCSCP8PS with 'Y' Hub | Medical Components, Inc. | 1982 | — |
| 0 (this device) | K001633 | Lifesite Hemodialysis Access System/Cannula Exchange, Model LHAS14120 &… | Vasca, Inc. | 2000 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 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 MSD? 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 12.4 · 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? (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 |
|---|---|---|---|
| * | K821684 | MCSCP8PS with 'Y' HubSummary page 1…Name: Blood Access Device and Accessories Classification Name: Blood Access Device and Accessories C. Predicate Device Name(s): Medcomp Tesio-Cath hemodialysis catheter K821684 Bard Access Systems BardPort Titanium Implanted Port, K913235 D. Devnce Description/Indications for Use: Description The LifeSit… | 1982 |
| * | K913235 | Davol Implant Ports W/Attach HI Perf Groshong CathSummary page 1…Blood Access Device and Accessories C. Predicate Device Name(s): Medcomp Tesio-Cath hemodialysis catheter K821684 Bard Access Systems BardPort Titanium Implanted Port, K913235 D. Devnce Description/Indications for Use: Description The LifeSite Hemodialysis Access System consists of two primary component… | 1991 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 22, 2003 | Not classified | Z-0045-04 | Other | Outer kit mislabeled with an extended expiration date |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 2 ancestors has a recall.
How does its category compare?
All MSD devicesMSD Catheter, Hemodialysis, Implanted: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
The LifeSite® Hemodialysis Access System provides fully-implantable blood access for patients who require hemodialysis while waiting for creation and/or maturation of permanent access. A 70% isopropyl alcohol solution is used in conjunction with the
LifeSite System for the localized cleansing of the injection site, valve pocket, and
LifeSite valve.
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/K001633 · printed Nov 5, 2026
Cite this page
510(k) Report. “K001633: Lifesite Hemodialysis Access System/Cannula Exchange, Model LHAS14120 & LHCEK0000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K001633
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026