510(k) · Cleared
ClearedReprocessed 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 Apr 3, 2012 as substantially equivalent to K012574 (Sterilmed, Inc., 2002) and 1 other predicate after a 71-day review. Its family tree reaches back 5 generations to 1995.
- Decided
- Apr 3, 2012
- Review
- 71 days
- Class
- Class II
- Product code
- NMF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K953781 (1995). 16 ancestors in all, the oldest K915280 (1992). No later device cites it as a predicate yet.
- Root · 5 generations backK953781 Innovative Technologies Calcium Alginate Wound DressingsInnovative Technologies, Ltd. · 1995
- 4 generations backK980989 3M Tegagen HI Alginate Dressing & 3M Tegagen HG Alginate DressingInnovative Technologies, Ltd. · 1998
- 3 generations backK010933 Seal-on Topical Hempstatic Powder SprayAlltracel Pharma, Ltd. · 2002
- 2 generations backK024107 Femostop Femoral Compression SystemRadi Medical Systems AB · 2002
- 1 generation backK080206 Modification to Femostop Femoral Compression SystemRadi Medical Systems AB · 2008
- This deviceK120204 Reprocessed Femoral Compression DeviceSterilmed, Inc. · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K953781 | Innovative Technologies Calcium Alginate Wound Dressings | Innovative Technologies, Ltd. | 1995 | — |
| −4 | K980989 | 3M Tegagen HI Alginate Dressing & 3M Tegagen HG Alginate Dressing | Innovative Technologies, Ltd. | 1998 | — |
| −3 | K010933 | Seal-on Topical Hempstatic Powder Spray | Alltracel Pharma, Ltd. | 2002 | — |
| −2 | K024107 | Femostop Femoral Compression System | Radi Medical Systems AB | 2002 | — |
| −1 | K080206 | Modification to Femostop Femoral Compression System | Radi Medical Systems AB | 2008 | — |
| 0 (this device) | K120204 | Reprocessed Femoral Compression Device | Sterilmed, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
| 2002 | 1 | 0 |
| 2007 | 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? (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 |
|---|---|---|---|
| * | K012574 | Reprocessed Femoral Compression Device | 2002 |
| * | K080206 | Modification to Femostop Femoral Compression SystemSummary page 1…mpression Devices: Device (KO 12574) with secondary substantial equivalence to the St. Jude Medical FemoStop Tm Gold Femoral Compression Systemn(K080206). Device The femoral compression device consists of an arch with a sterile pneumatic pressure dome and a connection ')e… | 2008 |
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?
- The line of descent spans 17 years and passes through 4 companies; a new generation was cleared every 3.6 years on median.
- 1 of the 16 ancestors has a recall of any class.
How does its category compare?
All NMF devicesNMF Clamp, Vascular, Reprocessed: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
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 as stated in the FDA summary.
https://510kreport.com/device/K120204 · printed Nov 5, 2026
Cite this page
510(k) Report. “K120204: Reprocessed Femoral Compression Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K120204
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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