510(k) · Cleared
ClearedPristine Hemodialysis Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pristine Access Technologies, Ltd. · MSD Catheter, Hemodialysis, Implanted
Cleared on May 31, 2019 as substantially equivalent to K111372 (Covidien, 2011) after a 266-day review. Its family tree reaches back 4 generations to 2001. 1 of the 9 devices in its family, counting itself, has a Class I recall. 2 later devices descend from it.
- Decided
- May 31, 2019
- Review
- 266 days
- Class
- Class II
- Product code
- MSD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K010399 (2001). 6 ancestors in all, the oldest K002901 (2001). 2 later devices descend from it, 1 citing it directly. 1 of the 9 devices in this family, counting this one, has a Class I recall.
- Root · 4 generations backK010399 Diatek Cannon-Cath #CC2400, CC2800, CC3200, CC3600,CC5500. CC2400PC…Diatek, Inc. · 2001 · Recalled
- 3 generations backK040078 Cannon II PlusArrow International, Inc. · 2004 · Recalled
- 2 generations backK092205 Palindrome P Hemodialysis CatheterCovidien Lp, Formerly Registered AS Kendall · 2009
- 1 generation backK111372 Tal Pallindrome (TM) Symmetric Tip Dual Lumen Catheter, Mahurkar (R)…Covidien · 2011 · Recalled (Class I)
- This deviceK182443 Pristine Hemodialysis CatheterPristine Access Technologies, Ltd. · 2019
- Descendant · cites it directly · 1 of its ownK203767 Pristine Long-Term Hemodialysis CatheterC B Bard, Inc. · 2021
- Descendant · 2 generations on · 0 of its ownK241581 Hemodialysis CatheterHaolang Medical USA Corporation · 2025
Class I recalls in this family
- K111372 Tal Pallindrome (TM) Symmetric Tip Dual Lumen…direct predicate · 2011
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 |
|---|---|---|---|---|---|
| −4 | K010399 | Diatek Cannon-Cath #CC2400, CC2800, CC3200, CC3600,CC5500. CC2400PC, CC2800PC… | Diatek, Inc. | 2001 | 2 |
| −3 | K040078 | Cannon II Plus | Arrow International, Inc. | 2004 | 19 |
| −2 | K092205 | Palindrome P Hemodialysis Catheter | Covidien Lp, Formerly Registered AS Kendall | 2009 | — |
| −1 | K111372 | Tal Pallindrome (TM) Symmetric Tip Dual Lumen Catheter, Mahurkar (R) Maxid… | Covidien | 2011 | Class I |
| 0 (this device) | K182443 | Pristine Hemodialysis Catheter | Pristine Access Technologies, Ltd. | 2019 | — |
| +1 | K203767 | Pristine Long-Term Hemodialysis Catheter | C B Bard, Inc. | 2021 | — |
| +2 | K241581 | Hemodialysis Catheter | Haolang Medical USA Corporation | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 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.
1 device in this family has 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? (1)
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 |
|---|---|---|---|
| * | K111372 | Tal Pallindrome (TM) Symmetric Tip Dual Lumen Catheter, Mahurkar (R) Maxid (TM) Dual…Summary page 4…Hemodialysis Catheter is substantially equivalent to the following predicate device: • Covidien TAL Palindrome Symmetric Tip Dual Lumen Catheter cleared under K111372 (product code MSD, Regulation No. 876.5540). 5-2… | 2011 |
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 |
|---|---|---|---|
| K203767 | Pristine Long-Term Hemodialysis Catheter | 2021 | 1 |
Has anything in its family been recalled? (1 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.
- K111372Tal Pallindrome (TM) Symmetric Tip Dual Lumen Catheter, Mahurkar (R) Maxid (TM) Dual Lumen Catheter…Covidien · 2011 · Direct predicate · ◆ on the line of descent in FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 18 years and passes through 5 companies; a new generation was cleared every 5.7 years on median.
- 3 of the 6 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K203767 (C B Bard, Inc., 2021) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K111372.
How does its category compare?
All MSD devicesMSD Catheter, Hemodialysis, Implanted: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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?
The Pristine™ Hemodialysis Catheter is indicated for acute and chronic hemodialysis, apheresis and infusion. It may be inserted percutaneously or by cut down. Catheters with greater than 40cm implant length are indicated for femoral placement.
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/K182443 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182443: Pristine Hemodialysis Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K182443
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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