510(k) · Cleared
ClearedPosisep and Posisep X Hemostat Dressing/Intranasal Splint
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hemostasis, LLC · LYA Splint, Intranasal Septal
Cleared on Mar 27, 2013 as substantially equivalent to K120958 (Hemostasis, LLC, 2012) and 3 other predicates after a 223-day review. Its family tree reaches back 7 generations to 1990. 2 later devices descend from it.
- Decided
- Mar 27, 2013
- Review
- 223 days
- Class
- Class I
- Product code
- LYA
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 7 generations to K896068 (1990). 41 ancestors in all, the oldest K821150 (1982). 2 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK896068 Tipstop (TM)Gambro-Hospal, Inc. · 1990
- 6 generations backK982818 Hospal TipstopGambro Healthcare · 1998
- 5 generations backK012293 Vascular Solutions Duett Flowable HemostatVascular Solutions, Inc. · 2002
- 4 generations backK030836 D-Stat-Dry Hemostatic Bandage; D-Stat Radial Hemostatic BandageVascular Solutions, Inc. · 2003 · Recalled
- 3 generations backK050511 Thrombigel Thrombin/Gelatin Foam HemostatVascular Solutions, Inc. · 2005
- 2 generations backK072900 Excelarrest FoamHemostasis, LLC · 2007
- 1 generation backK120958 Posisep and Posisep X Hemostat DressingsHemostasis, LLC · 2012
- This deviceK122494 Posisep and Posisep X Hemostat Dressing/Intranasal SplintHemostasis, LLC · 2013
- Descendant · cites it directly · 0 of its ownK181696 ChitoZolveGyrus Acmi, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK141816 HemoporePolyganics B.V., · 2014
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K896068 | Tipstop (TM) | Gambro-Hospal, Inc. | 1990 | — |
| −6 | K982818 | Hospal Tipstop | Gambro Healthcare | 1998 | — |
| −5 | K012293 | Vascular Solutions Duett Flowable Hemostat | Vascular Solutions, Inc. | 2002 | — |
| −4 | K030836 | D-Stat-Dry Hemostatic Bandage; D-Stat Radial Hemostatic Bandage | Vascular Solutions, Inc. | 2003 | 3 |
| −3 | K050511 | Thrombigel Thrombin/Gelatin Foam Hemostat | Vascular Solutions, Inc. | 2005 | — |
| −2 | K072900 | Excelarrest Foam | Hemostasis, LLC | 2007 | — |
| −1 | K120958 | Posisep and Posisep X Hemostat Dressings | Hemostasis, LLC | 2012 | — |
| 0 (this device) | K122494 | Posisep and Posisep X Hemostat Dressing/Intranasal Splint | Hemostasis, LLC | 2013 | — |
| +1 | K181696 | ChitoZolve | Gyrus Acmi, Inc. | 2018 | — |
| +1 | K141816 | Hemopore | Polyganics B.V., | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1983 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1997 | 4 | 0 |
| 1998 | 1 | 0 |
| 1999 | 3 | 0 |
| 2000 | 5 | 0 |
| 2001 | 3 | 0 |
| 2002 | 2 | 0 |
| 2003 | 3 | 0 |
| 2004 | 1 | 0 |
| 2005 | 3 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2018 | 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 LYA? 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 LYA device
- #1 K243655 TurbAlignscore 10.0 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K120958 | Posisep and Posisep X Hemostat DressingsSummary page 2…p ' X Hemostat Dressing/Intranasal Splint are substantially equivalent to the following predicate devices: *Hemostasis PoSiSep Tm and PosiSep TM X Topical Hemostat K120958 *CogENT Therapeutics Nasal/Epistaxis Pack KI 13585 *MeroGel Nasal Dressing and Sinus Stent K982731I *MeroPack N… | 2012 |
| * | K113585 | Nasal/Epistaxis Pack | 2012 |
| * | K982731 | Merogel Nasal Dressing and Sinus StentSummary page 2…*Hemostasis PoSiSep Tm and PosiSep TM X Topical Hemostat K120958 *CogENT Therapeutics Nasal/Epistaxis Pack KI 13585 *MeroGel Nasal Dressing and Sinus Stent K982731I *MeroPack Nasal Dressing and Sinus Stent K041381 Biocompatibility:. Biocompatibility testing was performed using ISO 1099… | 1999 |
| * | K041381 | Meropack Bioresorbable Nasal Packing and Sinus StentSummary page 2…at K120958 *CogENT Therapeutics Nasal/Epistaxis Pack KI 13585 *MeroGel Nasal Dressing and Sinus Stent K982731I *MeroPack Nasal Dressing and Sinus Stent K041381 Biocompatibility:. Biocompatibility testing was performed using ISO 10993 - Biological Evaluation of Medical Devices and FDA gui… | 2004 |
What descends from it? (2)
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?
- The line of descent spans 23 years and passes through 4 companies; a new generation was cleared every 2.5 years on median.
- 2 of the 41 ancestors have a recall of any class.
- Of its descendants, K181696 (Gyrus Acmi, Inc., 2018) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K120958.
How does its category compare?
All LYA devicesLYA Splint, Intranasal Septal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · LYA
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LYA
104in 2014
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LYA
No recall names LYA since 2007.
Adverse event reports per year · LYA
1in 2025
MAUDE reports naming product code LYA, 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 | 1 | — | 0 | 2 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 5 |
| 2010 | 0 | — | 0 | 2 |
| 2011 | 0 | — | 0 | 16 |
| 2012 | 1 | — | 0 | 16 |
| 2013 | 2 | — | 0 | 1 |
| 2014 | 5 | 104 | 0 | 4 |
| 2015 | 0 | — | 0 | 28 |
| 2016 | 1 | — | 0 | 28 |
| 2017 | 2 | — | 0 | 10 |
| 2018 | 2 | — | 0 | 19 |
| 2019 | 0 | — | 0 | 5 |
| 2020 | 1 | — | 0 | 6 |
| 2021 | 1 | — | 0 | 19 |
| 2022 | 0 | — | 0 | 8 |
| 2023 | 1 | — | 0 | 17 |
| 2024 | 0 | — | 0 | 7 |
| 2025 | 1 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
PosiSep and PosiSep M X Hemostat Dressing/Intranasal Splint are indicated for use in patients undergoing nasal/sinus surgery as a space occupying hemostat/splint to:
* Separate tissue or stmuctures compromised by surgical trauma;
* Separate and prevent adhesions between mucosal surfaces during mesothelial cell regeneration in the nasal cavity;
* Help control minimal bleeding following surgery or trauma;
* Help control minimal bleeding following surgery or nasal trauma by tamponade effect, blood absorption and platelet aggregation; and
* Act as an adjunct to aid in the natural healing process
PosiSep and PosiSep M X are intended for use under the direction of a licensed healthcare provider.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122494 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122494: Posisep and Posisep X Hemostat Dressing/Intranasal Splint.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122494
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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