510(k) · Cleared
ClearedPosiSep EAR Fragmentable Ear Dressing
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hemostasis, LLC · NHB Polymer, Ear, Nose And Throat, Synthetic, Absorbable
Cleared on May 5, 2022 as substantially equivalent to K070715 (Polyganics B.V.,, 2007) after a 448-day review. Its family tree reaches back 4 generations to 1997.
- Decided
- May 5, 2022
- Review
- 448 days
- Class
- Class II
- Product code
- NHB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K972082 (1997). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK972082 Custom Nasal SplintBoston Medical Products, Inc. · 1997
- 3 generations backK012532 Sepragel SinusGenzyme Corp. · 2001
- 2 generations backK052099 Nasopore Nasal Dressing, Model Ndox-Yyy/ZZPolyganics B.V., · 2005
- 1 generation backK070715 Nasopore EarPolyganics B.V., · 2007 · Recalled
- This deviceK210411 PosiSep EAR Fragmentable Ear DressingHemostasis, LLC · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K972082 | Custom Nasal Splint | Boston Medical Products, Inc. | 1997 | — |
| −3 | K012532 | Sepragel Sinus | Genzyme Corp. | 2001 | — |
| −2 | K052099 | Nasopore Nasal Dressing, Model Ndox-Yyy/ZZ | Polyganics B.V., | 2005 | — |
| −1 | K070715 | Nasopore Ear | Polyganics B.V., | 2007 | 13 |
| 0 (this device) | K210411 | PosiSep EAR Fragmentable Ear Dressing | Hemostasis, LLC | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 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 NHB? 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 NHB device
- #1 K251790 SeptAlignscore 14.9 · 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? (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 |
|---|---|---|---|
| * | K070715 | Nasopore EarSummary page 5…ng Classification Name: ENT Synthetic Polymer Material Product Code NHB, Class II, 21 CFR 874.3620 Predicate Device: NasoPore® K070715 Reference Devices: PosiSep/PosiSep X K120958/K122494 Establishment Registration Number: 3007225047 Description: Th… | 2007 |
| † | K120958 | Posisep and Posisep X Hemostat Dressings | 2012 |
| † | K122494 | Posisep and Posisep X Hemostat Dressing/Intranasal Splint | 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 25 years and passes through 4 companies; a new generation was cleared every 4.3 years on median.
- 1 of the 8 ancestors has a recall of any class.
How does its category compare?
All NHB devicesNHB Polymer, Ear, Nose And Throat, Synthetic, Absorbable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · NHB
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · NHB
Too few NHB 510(k)s in any year since 2007 to give a median.
Recalls per year · NHB
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NHB
22in 2025
MAUDE reports naming product code NHB, 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 | 2 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 3 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 1 | — | 0 | 2 |
| 2015 | 1 | — | 0 | 8 |
| 2016 | 1 | — | 0 | 9 |
| 2017 | 0 | — | 0 | 22 |
| 2018 | 0 | — | 0 | 17 |
| 2019 | 2 | — | 1 | 27 |
| 2020 | 0 | — | 0 | 6 |
| 2021 | 0 | — | 0 | 16 |
| 2022 | 1 | — | 0 | 9 |
| 2023 | 1 | — | 0 | 8 |
| 2024 | 1 | — | 0 | 19 |
| 2025 | 0 | — | 0 | 22 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
PosiSep® EAR Fragmentable Ear Dressing is indicated for use in patients undergoing outer ear surgery:
As a space occupying stent to separate and prevent adhesions between mucosal surfaces; and
To help control minimal bleeding following surgery or trauma by tamponade effect, blood absorption and platelet aggregation.
PosiSep® Ear is intended for use under the direction of a licensed healthcare provider.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K210411 · printed Nov 4, 2026
Cite this page
510(k) Report. “K210411: PosiSep EAR Fragmentable Ear Dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K210411
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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