510(k) · Cleared
ClearedSingle Lumen Embolectomy Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
American Biomed, Inc. · DXE Catheter, Embolectomy
Cleared on Jan 13, 1998 as substantially equivalent to K881455 (Cathlab Corp., 1988) and 1 other predicate after a 187-day review. Its family tree reaches back 1 generation to 1988.
- Decided
- Jan 13, 1998
- Review
- 187 days
- Class
- Class II
- Product code
- DXE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K881455 (1988). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK881455 Embolectomy Catheter (Modified)Cathlab Corp. · 1988
- This deviceK972572 Single Lumen Embolectomy CatheterAmerican Biomed, Inc. · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K881455 | Embolectomy Catheter (Modified) | Cathlab Corp. | 1988 | — |
| 0 (this device) | K972572 | Single Lumen Embolectomy Catheter | American Biomed, Inc. | 1998 | — |
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 DXE? 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 DXE device
- #1 K240078 Fogarty Thru-Lumen Embolectomy Catheterscore 7.9 · 1 generation · 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 |
|---|---|---|---|
| * | K881455 | Embolectomy Catheter (Modified)Summary page 2AN 13 1608 Section 2 ‘1 510(k) Summary ' Single Lumen Embolectomy Catheter American BioMed, Inc. | The Woodlands, Texas 77380 K881455 & K905139 MODIFICATION SUBMISSION American BioMed, Inc. July 1997 Steven Rash . President and CEO American BioMed, Inc P. O.… | 1988 |
| * | K905139 | Cathlab Silicone Arterial Embolectomy CatheterSummary page 2AN 13 1608 Section 2 ‘1 510(k) Summary ' Single Lumen Embolectomy Catheter American BioMed, Inc. | The Woodlands, Texas 77380 K881455 & K905139 MODIFICATION SUBMISSION American BioMed, Inc. July 1997 Steven Rash . President and CEO American BioMed, Inc P. O. Box 8429… | 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)
No FDA recall names this device.
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 DXE devicesDXE Catheter, Embolectomy: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DXE
5in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · DXE
173in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DXE
1in 2023
Class I (4 since 2007) Class II/III not classified
Adverse event reports per year · DXE
306in 2025
MAUDE reports naming product code DXE, 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 | — | 3 | 167 |
| 2008 | 1 | — | 0 | 134 |
| 2009 | 0 | — | 5 | 124 |
| 2010 | 2 | — | 1 | 136 |
| 2011 | 0 | — | 1 | 164 |
| 2012 | 0 | — | 0 | 200 |
| 2013 | 0 | — | 0 | 150 |
| 2014 | 0 | — | 0 | 192 |
| 2015 | 1 | — | 13 | 266 |
| 2016 | 0 | — | 0 | 796 |
| 2017 | 2 | — | 0 | 770 |
| 2018 | 0 | — | 0 | 615 |
| 2019 | 0 | — | 0 | 594 |
| 2020 | 1 | — | 0 | 547 |
| 2021 | 1 | — | 4 (4) | 333 |
| 2022 | 1 | — | 3 | 463 |
| 2023 | 0 | — | 1 | 436 |
| 2024 | 5 | 173 | 0 | 377 |
| 2025 | 0 | — | 0 | 306 |
| 2026 | 0 | — | 2 | — |
What is it indicated for?
Removing arterial emboli.
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/K972572 · printed Nov 6, 2026
Cite this page
510(k) Report. “K972572: Single Lumen Embolectomy Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K972572
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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