510(k) · Cleared
Recalled · 2008Reprocessed Femoral Compression Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sterilmed, Inc. · NMF Clamp, Vascular, Reprocessed
Cleared on Jul 18, 2002 as substantially equivalent to K915280 (Radi Medical Systems AB, 1992) after a 343-day review. Its family tree reaches back 1 generation to 1992. 1 later device descends from it. It has been recalled once.
- Decided
- Jul 18, 2002
- Review
- 343 days
- Class
- Class II
- Product code
- NMF
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K915280 (1992). 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K120204Reprocessed Femoral Compression DeviceSterilmed, Inc. · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K915280 | Femostop | Radi Medical Systems AB | 1992 | — |
| 0 (this device) | K012574 | Reprocessed Femoral Compression Device | Sterilmed, Inc. | 2002 | — |
| +1 | K120204 | Reprocessed Femoral Compression Device | Sterilmed, Inc. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 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 |
|---|---|---|---|
| * | K915280 | FemostopSummary page 6…ates. ‘h. Substantial Equivalence: SterilMed, Inc. considers the reprocessed femoral compression device to be substantially equivalent to: ' ' e The Femostop System® (K915280), manufactured by RADI Medical Systems i Performance Standards: There are no specific standards promulgated by the FDA that appl… | 1992 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K120204 | Reprocessed Femoral Compression Device | 2012 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 8, 2008 | Not classified | Z-0557-2009 | Packaging process control | SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed within a pouch. The removal is being conducted because the possibility exists that some of the pouches were not properly sealed on… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
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 reprocessed femoral compression device is intended for use in the compression of
the femoral artery or vein after 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/K012574 · printed Nov 4, 2026
Cite this page
510(k) Report. “K012574: 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/K012574
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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