510(k) · Cleared
Recalled · 2010Vanguard Reprocessed Femoral Compression Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vanguard Medical Concepts, Inc. · NMF Clamp, Vascular, Reprocessed
Cleared on Dec 21, 2001 as substantially equivalent to K983471 (Radi Medical Systems AB, 1999) after a 192-day review. Its family tree reaches back 2 generations to 1995. It has been recalled once.
- Decided
- Dec 21, 2001
- Review
- 192 days
- Class
- Class II
- Product code
- NMF
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K954669 (1995). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK954669 Femostop, Femostop PumpRadi Medical Systems AB · 1995
- 1 generation backK983471 Femostop Compression Arch, Femostop Pump, Femostop Bilateral AdapterRadi Medical Systems AB · 1999
- This deviceK011832 Vanguard Reprocessed Femoral Compression DeviceVanguard Medical Concepts, Inc. · 2001
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K954669 | Femostop, Femostop Pump | Radi Medical Systems AB | 1995 | — |
| −1 | K983471 | Femostop Compression Arch, Femostop Pump, Femostop Bilateral Adapter | Radi Medical Systems AB | 1999 | — |
| 0 (this device) | K011832 | Vanguard Reprocessed Femoral Compression Device | Vanguard Medical Concepts, Inc. | 2001 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 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 NMF? 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 |
|---|---|---|---|
| * | K983471 | Femostop Compression Arch, Femostop Pump, Femostop Bilateral AdapterSummary page 5…p — Class 11 Product Code DXC USCI® C. R. Bard®, Inc., RADI Medical Systems AB FemoStop® Femoral Compression System legally marketed under 510(k) premarket notification K983471 ‘ The femoral compression system is indicated for the compression of the femoral artery or vein following catheterization. Cont… | 1999 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 23, 2010 | Not classified | Z-2196-2010 | Reprocessing Controls | The FemoStop Devices may fail to inflate or hold pressure. A separation between the dome and arch base prevents the device from maintaining pressure when inflated. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 6 years and passes through 2 companies; a new generation was cleared every 3.3 years on median.
- None of the 3 ancestors has a recall.
- 1 other device also cites its predicate K983471.
How does its category compare?
All NMF devicesNMF Clamp, Vascular, Reprocessed: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NMF
1in 2012
2026 to Oct 25, outlined.
Median 510(k) review, days · NMF
Too few NMF 510(k)s in any year since 2007 to give a median.
Recalls per year · NMF
1in 2010
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NMF
2in 2013
MAUDE reports naming product code NMF, 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 | 0 |
| 2008 | 0 | — | 1 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 1 | 28 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 2 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The femoral compression system is indicated for the compression of the femoral artery or vein following catheterization.
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/K011832 · printed Nov 4, 2026
Cite this page
510(k) Report. “K011832: Vanguard Reprocessed Femoral Compression Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K011832
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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