510(k) · Cleared
ClearedEpi-Stop Epistaxis Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Medical Products, Inc. · EMX Balloon, Epistaxis
Cleared on Jun 26, 1997 after a 23-day review. The FDA summary names its predicate without a number. 5 later devices descend from it.
- Decided
- Jun 26, 1997
- Review
- 23 days
- Class
- Class I
- Product code
- EMX
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 1 citing it directly.
- This deviceK972077 Epi-Stop Epistaxis CatheterBoston Medical Products, Inc. · 1997
- Descendant · cites it directly · 4 of its ownK060289 Epistat, V-Stat, Models Epistat-001-01, V-Stat-001-01Frontline Medical · 2006
- Descendant · 2 generations on · 2 of its ownK091958 Belfort-Dildy Obstetric Tamponade SystemGlenveigh Surgical, LLC · 2010
- Descendant · 3 generations on · 1 of its ownK150573 ebb Complete Tamponade SystemClinical Innovations, LLC · 2015 · Recalled
- Descendant · 4 generations on · 0 of its ownK153591 ebb Complete Tamponade SystemClinical Innovations, LLC · 2016
- Descendant · 2 generations on · 0 of its ownK093904 Glenveigh Vaginal Tamponade Balloon CatheterGlenveigh Surgical, LLC · 2010
Most influential descendants
Showing 5 of 5 · See all- K060289Epistat, V-Stat, Models Epistat-001-01, V-Stat-001-01Frontline Medical · 2006 · cites it directly4descendants
- K091958Belfort-Dildy Obstetric Tamponade SystemGlenveigh Surgical, LLC · 2010 · 2 generations on2descendants
- K150573ebb Complete Tamponade SystemClinical Innovations, LLC · 2015 · 3 generations on1descendant
- K153591ebb Complete Tamponade SystemClinical Innovations, LLC · 2016 · 4 generations on0descendants
- K093904Glenveigh Vaginal Tamponade Balloon CatheterGlenveigh Surgical, LLC · 2010 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K972077 | Epi-Stop Epistaxis Catheter | Boston Medical Products, Inc. | 1997 | — |
| +1 | K060289 | Epistat, V-Stat, Models Epistat-001-01, V-Stat-001-01 | Frontline Medical | 2006 | — |
| +2 | K091958 | Belfort-Dildy Obstetric Tamponade System | Glenveigh Surgical, LLC | 2010 | — |
| +3 | K150573 | ebb Complete Tamponade System | Clinical Innovations, LLC | 2015 | 1 |
| +4 | K153591 | ebb Complete Tamponade System | Clinical Innovations, LLC | 2016 | — |
| +2 | K093904 | Glenveigh Vaginal Tamponade Balloon Catheter | Glenveigh Surgical, LLC | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2010 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 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 EMX? 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 EMX device
- #1 K220326 PosiSep X BAM Hemostat Dressing/Intranasal…score 4.3 · 1 generation · no Class I recall
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 |
|---|---|---|---|
| * | — | Product No. 20-10715 Named without a submission number |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K060289 | Epistat, V-Stat, Models Epistat-001-01, V-Stat-001-01 | 2006 | 4 |
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?
- Of its descendants, K060289 (Frontline Medical, 2006) has gone furthest, with 4 descendants of its own.
How does its category compare?
All EMX devicesEMX Balloon, Epistaxis: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EMX
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · EMX
Too few EMX 510(k)s in any year since 2007 to give a median.
Recalls per year · EMX
No recall names EMX since 2007.
Adverse event reports per year · EMX
16in 2025
MAUDE reports naming product code EMX, 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 | 3 |
| 2008 | 0 | — | 0 | 3 |
| 2009 | 0 | — | 0 | 3 |
| 2010 | 0 | — | 0 | 3 |
| 2011 | 0 | — | 0 | 10 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 3 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 3 |
| 2019 | 0 | — | 0 | 12 |
| 2020 | 0 | — | 0 | 5 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 3 |
| 2024 | 0 | — | 0 | 12 |
| 2025 | 0 | — | 0 | 16 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
1. To be used for control of anterior nasal epistaxis.
2. To be used as a nasal packing following septoplasty, rhinoplasty, and other intra-nasal surgical procedures.
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/K972077 · printed Nov 5, 2026
Cite this page
510(k) Report. “K972077: Epi-Stop Epistaxis Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K972077
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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