510(k) · Cleared
ClearedMedcomp Ash Split
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medical Components, Inc. · NFK Kit, Repair, Catheter, Hemodialysis
Cleared on Jun 21, 2001 as substantially equivalent to K972207 (Medcomp, 1998) after a 30-day review. Its family tree reaches back 1 generation to 1998.
- Decided
- Jun 21, 2001
- Review
- 30 days
- Class
- Class II
- Product code
- NFK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K972207 (1998). No later device cites it as a predicate yet.
- Root · 1 generation backK972207 Medcomp Ash Split-Cath 28CM, Medcomp Ash Split-Cath 32CMMedcomp · 1998
- This deviceK011576 Medcomp Ash SplitMedical Components, Inc. · 2001
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) | K011576 | Medcomp Ash Split | Medical Components, Inc. | 2001 | — |
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 NFK? 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? (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 |
|---|---|---|---|
| * | K972207 | Medcomp Ash Split-Cath 28CM, Medcomp Ash Split-Cath 32CMSummary page 1…Jeanne M. Cush Senior Regulatory Affairs Associate Date Prepared: May 14, 2001 Special 510(k) Corrective Action Being Affected Product Affected: Medcomp Ash Split- Cath K972207 Product Modification: Addition of Safety Slide Clamp Classification: 78 MSD C.F.R. Section: 876.5540 Description of Device Modi… | 1998 |
What descends from it?
No later submission names this one as a predicate yet.
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.
- 4 other devices also cite its predicate K972207.
How does its category compare?
All NFK devicesNFK Kit, Repair, Catheter, Hemodialysis: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NFK
1in 2010
2026 to Oct 25, outlined.
Median 510(k) review, days · NFK
Too few NFK 510(k)s in any year since 2007 to give a median.
Recalls per year · NFK
No recall names NFK since 2007.
Adverse event reports per year · NFK
18in 2025
MAUDE reports naming product code NFK, 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 | 1 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 2 |
| 2010 | 1 | — | 0 | 3 |
| 2011 | 0 | — | 0 | 16 |
| 2012 | 0 | — | 0 | 11 |
| 2013 | 0 | — | 0 | 16 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 7 |
| 2017 | 0 | — | 0 | 8 |
| 2018 | 0 | — | 0 | 5 |
| 2019 | 0 | — | 0 | 5 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 18 |
| 2023 | 0 | — | 0 | 4 |
| 2024 | 0 | — | 0 | 19 |
| 2025 | 0 | — | 0 | 18 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Medcomp Safety Slide Clamp is intended to provide a secondary extension tube clamp on the Medcomp Ash Split-Cath, Duo-Flow 400XL and Duo-Split Catheters to prevent leakage during connection or disconnection of the bloodlines.
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/K011576 · printed Nov 5, 2026
Cite this page
510(k) Report. “K011576: Medcomp Ash Split.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K011576
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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