510(k) · Cleared

Cleared

14F X 24CM Ash Split-Cath,14F X 28CM Ash Split-Cath, 14F X 32CM Ash Split-Cath, 14FX36CM Ash Split-Cath, 14F X 40CM Ash

K013162510(k) SpecialCleared Oct 19, 200128-day reviewClass II21 CFR 876.5980

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Medcomp · KNT Tubes, Gastrointestinal (And Accessories)

Cleared on Oct 19, 2001 as substantially equivalent to K972207 (Medcomp, 1998) after a 28-day review. Its family tree reaches back 1 generation to 1998. 5 later devices descend from it.

Decided: Oct 19, 2001
Review: 28 days
Class: Class II
Product code: KNT
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K972207 (1998). 5 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK972207 Medcomp Ash Split-Cath 28CM, Medcomp Ash Split-Cath 32CMMedcomp · 1998
This deviceK013162 14F X 24CM Ash Split-Cath,14F X 28CM Ash Split-Cath, 14F X 32CM Ash…Medcomp · 2001
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
Descendant · cites it directly · 0 of its ownK020315 14F X 55CM Ash Split-Cath XL, Model ASPC55-XLMedcomp · 2002

Most influential descendants

Showing 5 of 5 · 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
K02031514F X 55CM Ash Split-Cath XL, Model ASPC55-XLMedcomp · 2002 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K972207	Medcomp Ash Split-Cath 28CM, Medcomp Ash Split-Cath 32CM	Medcomp	1998	—
0 (this device)	K013162	14F X 24CM Ash Split-Cath,14F X 28CM Ash Split-Cath, 14F X 32CM Ash…	Medcomp	2001	—
+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	—
+1	K020315	14F X 55CM Ash Split-Cath XL, Model ASPC55-XL	Medcomp	2002	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	2	0
2020	2	0
2025	1	0

FIG. 1 — Lineage of K013162, 1998–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 KNT? 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 KNT device

#1 K261890 52Fr ViSiGi LUX™; 52Fr ViSiGi 3D®score 12.7 · 4 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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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	Applicant	Decided	Recalls
*	K972207	Medcomp Ash Split-Cath 28CM, Medcomp Ash Split-Cath 32CM Summary page 1 …ared: July 25, 2001 Trade Name: Medcomp Ash Split-Cath Common Name: Hemodialysis Catheter, Implanted Classification: 78 MSD C.F.R. Section: 876.5540 Predicate Device: K972207 Medcomp Ash Split-Cath Device Description: The Medcomp Ash Split-Cath is a polyurethane, double lumen catheter used to remove a…	Medcomp	1998	—

Also cleared against K972207: 4 other devices →

What descends from it? (5)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K020936	10F X 18CM Pediatric Ash Split Cath XL, Model ASPC18P-XL; 10F X 24CM Pediatric Ash…	Medcomp	2002	3
K020315	14F X 55CM Ash Split-Cath XL, Model ASPC55-XL	Medcomp	2002	0

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K020936 (Medcomp, 2002) has gone furthest, with 3 descendants of its own.
4 other devices also cite its predicate K972207.

How does its category compare?

All KNT devices

KNT Tubes, Gastrointestinal (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KNT

4in 2025

2007high 16 (2014) · low 4 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KNT

136in 2025

2007high 259 (2014) · low 99 (2016)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · KNT

13in 2025

2007high 82 (2008) · low 0 (2013)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · KNT

1,451in 2025

2007high 1,901 (2018) · low 300 (2007)2025

MAUDE reports naming product code KNT, 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	10	118	1	300
2008	10	115	82	867
2009	11	102	9	818
2010	12	104	3	517
2011	7	211	2	531
2012	12	107	1	528
2013	7	128	0	747
2014	16	259	0	1,030
2015	10	140	1	1,048
2016	6	99	3	1,251
2017	9	247	4	1,672
2018	7	149	2	1,901
2019	10	126	2	1,838
2020	5	102	1	1,641
2021	6	121	2	1,655
2022	7	110	1 (1)	1,650
2023	5	162	2	1,863
2024	9	103	0	1,344
2025	4	136	13	1,451
2026	3	105	20	—

What is it indicated for?

The Medcomp Ash Split-Cath is indicated for use in attaining long-term vascular access for hemodialysis and apheresis. It may be inserted percutaneously and is ideally placed in the internal jugular vein of an adult patient. Alternate insertion site includes the subclavian vein as required.

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/K013162 · printed Nov 6, 2026

Cite this page

510(k) Report. “K013162: 14F X 24CM Ash Split-Cath,14F X 28CM Ash Split-Cath, 14F X 32CM Ash Split-Cath, 14FX36CM Ash Split-Cath, 14F X 40CM Ash.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013162

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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