510(k) · Cleared
Recalled · Class I · 2026Pediatric Two-Lumen Hemodialysis Catherization Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arrow Intl., Inc. · MPB Catheter, Hemodialysis, Non-Implanted
Cleared on May 18, 1999 after a 187-day review. The FDA summary names its predicate without a number. 1 of the 5 devices in its family, counting itself, has a Class I recall. 4 later devices descend from it. It has been recalled once, including a Class I recall.
- Decided
- May 18, 1999
- Review
- 187 days
- Class
- Class II
- Product code
- MPB
- Recalls
- 1 (1 Class I)
- Predicates
- 0
4 later devices descend from it, 1 citing it directly. 1 of the 5 devices in this family, counting this one, has a Class I recall.
- This deviceK984022 Pediatric Two-Lumen Hemodialysis Catherization KitArrow Intl., Inc. · 1999
- Descendant · cites it directly · 3 of its ownK020936 10F X 18CM Pediatric Ash Split Cath XL, Model ASPC18P-XL; 10F X 24CM…Medcomp · 2002
- Descendant · 2 generations on · 2 of its ownK200627 GlidePath 10F Long-Term Dialysis CatheterC.R. Bard, Inc. · 2020
- Descendant · 3 generations on · 1 of its ownK202150 GlidePath 7.5F Long-Term Dialysis CatheterC.R. Bard, Inc. · 2020
- Descendant · 4 generations on · 0 of its ownK241581 Hemodialysis CatheterHaolang Medical USA Corporation · 2025
Most influential descendants
Showing 4 of 4 · See all- K02093610F X 18CM Pediatric Ash Split Cath XL, Model ASPC18P-XL; 10F X 24CM Pediatric Ash…Medcomp · 2002 · cites it directly3descendants
- K200627GlidePath 10F Long-Term Dialysis CatheterC.R. Bard, Inc. · 2020 · 2 generations on2descendants
- K202150GlidePath 7.5F Long-Term Dialysis CatheterC.R. Bard, Inc. · 2020 · 3 generations on1descendant
- K241581Hemodialysis CatheterHaolang Medical USA Corporation · 2025 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K984022 | Pediatric Two-Lumen Hemodialysis Catherization Kit | Arrow Intl., Inc. | 1999 | — |
| +1 | K020936 | 10F X 18CM Pediatric Ash Split Cath XL, Model ASPC18P-XL; 10F X 24CM Pediatric… | Medcomp | 2002 | — |
| +2 | K200627 | GlidePath 10F Long-Term Dialysis Catheter | C.R. Bard, Inc. | 2020 | — |
| +3 | K202150 | GlidePath 7.5F Long-Term Dialysis Catheter | C.R. Bard, Inc. | 2020 | — |
| +4 | K241581 | Hemodialysis Catheter | Haolang Medical USA Corporation | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2020 | 2 | 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 MPB device
- #1 K250836 14F Duo-Flow® Side X Side Double Lumen Catheterscore 10.1 · 2 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 |
|---|---|---|---|
| * | — | ARROW Large-Bore Dual Lumen Hemodialysis Catheterization Kit Named without a submission number |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K020936 | 10F X 18CM Pediatric Ash Split Cath XL, Model ASPC18P-XL; 10F X 24CM Pediatric Ash… | 2002 | 3 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 21, 2026 | Class I | Z-2373-2026 | Nonconforming Material/Component | Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K020936 (Medcomp, 2002) has gone furthest, with 3 descendants of its own.
How does its category compare?
All MPB devicesMPB Catheter, Hemodialysis, Non-Implanted: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MPB
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MPB
205in 2020
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MPB
4so far in 2026, the most since 2007
Class I (3 since 2007) Class II/III not classified
Adverse event reports per year · MPB
187in 2025
MAUDE reports naming product code MPB, 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 | 3 | 136 | 1 | 41 |
| 2008 | 0 | — | 0 | 147 |
| 2009 | 1 | — | 0 | 166 |
| 2010 | 1 | — | 0 | 60 |
| 2011 | 2 | — | 0 | 74 |
| 2012 | 1 | — | 0 | 78 |
| 2013 | 1 | — | 0 | 124 |
| 2014 | 0 | — | 0 | 82 |
| 2015 | 0 | — | 0 | 51 |
| 2016 | 1 | — | 0 | 70 |
| 2017 | 2 | — | 2 | 86 |
| 2018 | 0 | — | 0 | 120 |
| 2019 | 0 | — | 0 | 119 |
| 2020 | 3 | 205 | 0 | 179 |
| 2021 | 0 | — | 0 | 192 |
| 2022 | 0 | — | 0 | 166 |
| 2023 | 0 | — | 0 | 203 |
| 2024 | 0 | — | 0 | 181 |
| 2025 | 1 | — | 0 | 187 |
| 2026 | 0 | — | 4 (3) | — |
What is it indicated for?
The dual-lumen hemodialysis catheter permits venous access to the central circulation system for rapid fluid administration, temporary or acute hemodialysis and apheresis . It may be inserted into the jugular, subclavian, or femoral veins of children, adolescents and small adults.
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/K984022 · printed Nov 5, 2026
Cite this page
510(k) Report. “K984022: Pediatric Two-Lumen Hemodialysis Catherization Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K984022
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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