510(k) · Cleared
ClearedChitoZolve
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gyrus Acmi, Inc. · LYA Splint, Intranasal Septal
Cleared on Nov 30, 2018 as substantially equivalent to K122494 (Hemostasis, LLC, 2013) after a 156-day review. Its family tree reaches back 8 generations to 1990.
- Decided
- Nov 30, 2018
- Review
- 156 days
- Class
- Class I
- Product code
- LYA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K896068 (1990). 42 ancestors in all, the oldest K821150 (1982). No later device cites it as a predicate yet.
- Root · 8 generations backK896068 Tipstop (TM)Gambro-Hospal, Inc. · 1990
- 7 generations backK982818 Hospal TipstopGambro Healthcare · 1998
- 6 generations backK012293 Vascular Solutions Duett Flowable HemostatVascular Solutions, Inc. · 2002
- 5 generations backK030836 D-Stat-Dry Hemostatic Bandage; D-Stat Radial Hemostatic BandageVascular Solutions, Inc. · 2003 · Recalled
- 4 generations backK050511 Thrombigel Thrombin/Gelatin Foam HemostatVascular Solutions, Inc. · 2005
- 3 generations backK072900 Excelarrest FoamHemostasis, LLC · 2007
- 2 generations backK120958 Posisep and Posisep X Hemostat DressingsHemostasis, LLC · 2012
- 1 generation backK122494 Posisep and Posisep X Hemostat Dressing/Intranasal SplintHemostasis, LLC · 2013
- This deviceK181696 ChitoZolveGyrus Acmi, Inc. · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K896068 | Tipstop (TM) | Gambro-Hospal, Inc. | 1990 | — |
| −7 | K982818 | Hospal Tipstop | Gambro Healthcare | 1998 | — |
| −6 | K012293 | Vascular Solutions Duett Flowable Hemostat | Vascular Solutions, Inc. | 2002 | — |
| −5 | K030836 | D-Stat-Dry Hemostatic Bandage; D-Stat Radial Hemostatic Bandage | Vascular Solutions, Inc. | 2003 | 3 |
| −4 | K050511 | Thrombigel Thrombin/Gelatin Foam Hemostat | Vascular Solutions, Inc. | 2005 | — |
| −3 | K072900 | Excelarrest Foam | Hemostasis, LLC | 2007 | — |
| −2 | K120958 | Posisep and Posisep X Hemostat Dressings | Hemostasis, LLC | 2012 | — |
| −1 | K122494 | Posisep and Posisep X Hemostat Dressing/Intranasal Splint | Hemostasis, LLC | 2013 | — |
| 0 (this device) | K181696 | ChitoZolve | Gyrus Acmi, Inc. | 2018 | — |
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 |
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? (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 |
|---|---|---|---|
| * | K122494 | Posisep and Posisep X Hemostat Dressing/Intranasal SplintSummary page 5…Traditional 510(k) Notification Gyrus ACMI, Inc. Predicate Device Hemostasis PosiSep / PosiSep X: K122494 Product Description Intranasal splints are utilized to stop nasal hemorrhage and for the prevention of tissue adhesion in the n… | 2013 |
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 28 years and passes through 5 companies; a new generation was cleared every 3.2 years on median.
- 2 of the 42 ancestors have a recall of any class.
- 1 other device also cites its predicate K122494.
How does its category compare?
All LYA devicesLYA Splint, Intranasal Septal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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?
Indicated for use in patients undergoing nasal/sinus surgery as a space occupying hemostat/splint to:
- Separate tissue or structures 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
- Act as an adjunct to aid in the natural healing process
Indicated for use as a nasal hemostat to treat epistaxis.
Intended for use under the direction of a licensed healthcare provider.
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/K181696 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181696: ChitoZolve.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181696
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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