510(k) · Cleared
ClearedPosisep and Posisep X Hemostat Dressings
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hemostasis, LLC · QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics
Cleared on Jul 25, 2012 as substantially equivalent to K072900 (Hemostasis, LLC, 2007) and 3 other predicates after a 117-day review. Its family tree reaches back 6 generations to 1990. 6 later devices descend from it.
- Decided
- Jul 25, 2012
- Review
- 117 days
- Class
- Class U
- Product code
- QSY
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 6 generations to K896068 (1990). 35 ancestors in all, the oldest K821150 (1982). 6 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK896068 Tipstop (TM)Gambro-Hospal, Inc. · 1990
- 5 generations backK982818 Hospal TipstopGambro Healthcare · 1998
- 4 generations backK012293 Vascular Solutions Duett Flowable HemostatVascular Solutions, Inc. · 2002
- 3 generations backK030836 D-Stat-Dry Hemostatic Bandage; D-Stat Radial Hemostatic BandageVascular Solutions, Inc. · 2003 · Recalled
- 2 generations backK050511 Thrombigel Thrombin/Gelatin Foam HemostatVascular Solutions, Inc. · 2005
- 1 generation backK072900 Excelarrest FoamHemostasis, LLC · 2007
- This deviceK120958 Posisep and Posisep X Hemostat DressingsHemostasis, LLC · 2012
- Descendant · cites it directly · 2 of its ownK141704 Novashield Injectable Nasal Packing and StentMedtronic, Inc. · 2014
- Descendant · cites it directly · 2 of its ownK122494 Posisep and Posisep X Hemostat Dressing/Intranasal SplintHemostasis, LLC · 2013
- Descendant · 2 generations on · 1 of its ownK172179 Chitogel Endoscopic Sinus Surgery KitChitogel, Ltd. · 2017
- Descendant · 3 generations on · 0 of its ownK230142 Epi-Stop Nasal Gel/epistaxis packBiomed Ent, Inc. · 2023
- Descendant · 2 generations on · 0 of its ownK181696 ChitoZolveGyrus Acmi, Inc. · 2018
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K141704Novashield Injectable Nasal Packing and StentMedtronic, Inc. · 2014 · cites it directly2descendants
- K122494Posisep and Posisep X Hemostat Dressing/Intranasal SplintHemostasis, LLC · 2013 · cites it directly2descendants
- K172179Chitogel Endoscopic Sinus Surgery KitChitogel, Ltd. · 2017 · 2 generations on1descendant
- K230142Epi-Stop Nasal Gel/epistaxis packBiomed Ent, Inc. · 2023 · 3 generations on0descendants
- K181696ChitoZolveGyrus Acmi, Inc. · 2018 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K896068 | Tipstop (TM) | Gambro-Hospal, Inc. | 1990 | — |
| −5 | K982818 | Hospal Tipstop | Gambro Healthcare | 1998 | — |
| −4 | K012293 | Vascular Solutions Duett Flowable Hemostat | Vascular Solutions, Inc. | 2002 | — |
| −3 | K030836 | D-Stat-Dry Hemostatic Bandage; D-Stat Radial Hemostatic Bandage | Vascular Solutions, Inc. | 2003 | 3 |
| −2 | K050511 | Thrombigel Thrombin/Gelatin Foam Hemostat | Vascular Solutions, Inc. | 2005 | — |
| −1 | K072900 | Excelarrest Foam | Hemostasis, LLC | 2007 | — |
| 0 (this device) | K120958 | Posisep and Posisep X Hemostat Dressings | Hemostasis, LLC | 2012 | — |
| +1 | K141704 | Novashield Injectable Nasal Packing and Stent | Medtronic, Inc. | 2014 | — |
| +1 | K122494 | Posisep and Posisep X Hemostat Dressing/Intranasal Splint | Hemostasis, LLC | 2013 | — |
| +2 | K172179 | Chitogel Endoscopic Sinus Surgery Kit | Chitogel, Ltd. | 2017 | — |
| +3 | K230142 | Epi-Stop Nasal Gel/epistaxis pack | Biomed Ent, Inc. | 2023 | — |
| +2 | 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 | 4 | 0 |
| 2001 | 3 | 0 |
| 2002 | 2 | 0 |
| 2003 | 3 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2023 | 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 QSY? 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 QSY device
- #1 K240713 Traumagel®score 15.1 · 5 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 |
|---|---|---|---|
| * | K072900 | Excelarrest FoamSummary page 6…e: TTM The PosiSepy and PosiSep X Hemostat Dressings are substantially equivalent to the following predicate devices: *Hemostasis ExcelArrest® Foam K072900 *Hemostasis NexFoam® Topical Hemostat K102459 *HemCon Bandage K043050/K072486 Hiocompatibility: Biocompatibility tes… | 2007 |
| * | K102459 | Nexstat (TM) Topical Hemostat Powder; Nexfoam (R) Topical SpongeSummary page 6…mostat Dressings are substantially equivalent to the following predicate devices: *Hemostasis ExcelArrest® Foam K072900 *Hemostasis NexFoam® Topical Hemostat K102459 *HemCon Bandage K043050/K072486 Hiocompatibility: Biocompatibility testing was performed using ISO 10993 - Biological Eval… | 2010 |
| * | K043050 | Hemcon Bandage and Hemcon Bandage OtcSummary page 6…ally equivalent to the following predicate devices: *Hemostasis ExcelArrest® Foam K072900 *Hemostasis NexFoam® Topical Hemostat K102459 *HemCon Bandage K043050/K072486 Hiocompatibility: Biocompatibility testing was performed using ISO 10993 - Biological Evaluation of Medical Devices and… | 2005 |
| * | K072486 | Modification to Hemcon Bandage and Hemcon Bandage OtcSummary page 6…ivalent to the following predicate devices: *Hemostasis ExcelArrest® Foam K072900 *Hemostasis NexFoam® Topical Hemostat K102459 *HemCon Bandage K043050/K072486 Hiocompatibility: Biocompatibility testing was performed using ISO 10993 - Biological Evaluation of Medical Devices and FDA guid… | 2008 |
What descends from it? (6)
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 22 years and passes through 4 companies; a new generation was cleared every 3.2 years on median.
- 2 of the 35 ancestors have a recall of any class.
- Of its descendants, K141704 (Medtronic, Inc., 2014) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K072900.
How does its category compare?
All QSY devicesQSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · QSY
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QSY
142in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QSY
No recall names QSY since 2007.
Adverse event reports per year · QSY
14in 2025
MAUDE reports naming product code QSY, 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 | 13 | 63 | 0 | 0 |
| 2008 | 7 | 61 | 0 | 0 |
| 2009 | 9 | 55 | 0 | 0 |
| 2010 | 7 | 75 | 0 | 0 |
| 2011 | 8 | 137 | 0 | 0 |
| 2012 | 7 | 239 | 0 | 0 |
| 2013 | 3 | 161 | 0 | 0 |
| 2014 | 6 | 249 | 0 | 0 |
| 2015 | 6 | 171 | 0 | 0 |
| 2016 | 5 | 161 | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 5 | 186 | 0 | 0 |
| 2019 | 4 | 336 | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 2 | — | 0 | 1 |
| 2023 | 7 | 586 | 0 | 0 |
| 2024 | 4 | 142 | 0 | 3 |
| 2025 | 2 | — | 0 | 14 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
PosiSep M and PosiSep X Hemostat Dressings are topical dressings for the temporary treatment
of bleeding wounds such as surgical wounds (post operative, donor sites, dermatological), cuts
and lacerations and for the treatment of mild bleeding from topical ENT surgical wounds and
nosebleeds. PosiSepT and PosiSep 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/K120958 · printed Nov 4, 2026
Cite this page
510(k) Report. “K120958: Posisep and Posisep X Hemostat Dressings.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K120958
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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