510(k) · Cleared
ClearedEpistat, V-Stat, Models Epistat-001-01, V-Stat-001-01
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Frontline Medical · KNA Instrument, Manual, Specialized Obstetric-Gynecologic
Cleared on Jul 7, 2006 as substantially equivalent to K013597 (Cook Ob/Gyn, 2002) and 1 other predicate after a 151-day review. Its family tree reaches back 1 generation to 1997. 4 later devices descend from it.
- Decided
- Jul 7, 2006
- Review
- 151 days
- Class
- Class II
- Product code
- KNA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K972077 (1997). 2 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK972077 Epi-Stop Epistaxis CatheterBoston Medical Products, Inc. · 1997
- This deviceK060289 Epistat, V-Stat, Models Epistat-001-01, V-Stat-001-01Frontline Medical · 2006
- Descendant · cites it directly · 2 of its ownK091958 Belfort-Dildy Obstetric Tamponade SystemGlenveigh Surgical, LLC · 2010
- Descendant · 2 generations on · 1 of its ownK150573 ebb Complete Tamponade SystemClinical Innovations, LLC · 2015 · Recalled
- Descendant · 3 generations on · 0 of its ownK153591 ebb Complete Tamponade SystemClinical Innovations, LLC · 2016
- Descendant · cites it directly · 0 of its ownK093904 Glenveigh Vaginal Tamponade Balloon CatheterGlenveigh Surgical, LLC · 2010
Most influential descendants
Showing 4 of 4 · See all- K091958Belfort-Dildy Obstetric Tamponade SystemGlenveigh Surgical, LLC · 2010 · cites it directly2descendants
- K150573ebb Complete Tamponade SystemClinical Innovations, LLC · 2015 · 2 generations on1descendant
- K153591ebb Complete Tamponade SystemClinical Innovations, LLC · 2016 · 3 generations on0descendants
- K093904Glenveigh Vaginal Tamponade Balloon CatheterGlenveigh Surgical, LLC · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K972077 | Epi-Stop Epistaxis Catheter | Boston Medical Products, Inc. | 1997 | — |
| 0 (this device) | K060289 | Epistat, V-Stat, Models Epistat-001-01, V-Stat-001-01 | Frontline Medical | 2006 | — |
| +1 | K091958 | Belfort-Dildy Obstetric Tamponade System | Glenveigh Surgical, LLC | 2010 | — |
| +2 | K150573 | ebb Complete Tamponade System | Clinical Innovations, LLC | 2015 | 1 |
| +3 | K153591 | ebb Complete Tamponade System | Clinical Innovations, LLC | 2016 | — |
| +1 | K093904 | Glenveigh Vaginal Tamponade Balloon Catheter | Glenveigh Surgical, LLC | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 KNA? 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? (3)
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 |
|---|---|---|---|
| * | K013597 | Tamponade Uterine Balloon Catheter SetSummary page 1…s Packaging I) 2 Cook OB/GYN Tamponade Uterine Balloon K01 3597 Catheter Set 3 Boston Medical Products Epi-Stop Epistaxis Catheter… | 2002 |
| * | K972077 | Epi-Stop Epistaxis CatheterSummary page 1…Balloon K01 3597 Catheter Set 3 Boston Medical Products Epi-Stop Epistaxis Catheter K972077 (4) Description of the Device: EpiStat is an inflatable balloon tamponade device designed to provide a safe and effective metho… | 1997 |
| * | — | National Hospital Packaging Vag Packing Named without a submission number |
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
How does its category compare?
All KNA devicesKNA Instrument, Manual, Specialized Obstetric-Gynecologic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KNA
1in 2014
2026 to Oct 25, outlined.
Median 510(k) review, days · KNA
Too few KNA 510(k)s in any year since 2007 to give a median.
Recalls per year · KNA
No recall names KNA since 2007.
Adverse event reports per year · KNA
5in 2025
MAUDE reports naming product code KNA, 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 | 2 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 8 |
| 2011 | 1 | — | 0 | 13 |
| 2012 | 0 | — | 0 | 8 |
| 2013 | 0 | — | 0 | 2 |
| 2014 | 1 | — | 0 | 4 |
| 2015 | 0 | — | 0 | 8 |
| 2016 | 0 | — | 0 | 22 |
| 2017 | 0 | — | 0 | 37 |
| 2018 | 0 | — | 0 | 63 |
| 2019 | 0 | — | 0 | 5 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 4 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 5 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
EpiStat is intended for use by physicians and trained obstetrics/gynecology nurse practitioners during episiotomy repair procedures. EpiStat is intended to temporarily tamponade the post partum discharge from the vagina in order to assist with the episiotomy repair procedure.
V-Stat is intended for use by physicians for temporary haemostatic control following vaginal surgery procedures such as (a) post operative packing for posterior and anterior vaginal repairs (b) brisk introperative bleeding during urethral sling procedures and post operative packing to control sub-pubic haematoma following urethral sling procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060289 · printed Nov 4, 2026
Cite this page
510(k) Report. “K060289: Epistat, V-Stat, Models Epistat-001-01, V-Stat-001-01.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060289
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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