510(k) · Cleared

Cleared

PosiSep X BAM Hemostat Dressing/Intranasal Splint

K220326510(k) TraditionalCleared Nov 14, 2022283-day reviewClass I21 CFR 874.4100

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Hemostasis, LLC · EMX Balloon, Epistaxis

Cleared on Nov 14, 2022 as substantially equivalent to K983276 (Hydrofera, LLC, 1999) after a 283-day review. Its family tree reaches back 1 generation to 1999.

Decided: Nov 14, 2022
Review: 283 days
Class: Class I
Product code: EMX
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K983276 (1999). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK983276 Hydrofera Bacteristatic Nasal DressingHydrofera, LLC · 1999
This deviceK220326 PosiSep X BAM Hemostat Dressing/Intranasal SplintHemostasis, LLC · 2022

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K983276	Hydrofera Bacteristatic Nasal Dressing	Hydrofera, LLC	1999	—
0 (this device)	K220326	PosiSep X BAM Hemostat Dressing/Intranasal Splint	Hemostasis, LLC	2022	—

FIG. 1 — Lineage of K220326, 1999–2022Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 EMX? 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

Get a 510(k) 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	Applicant	Decided	Recalls
*	K983276	Hydrofera Bacteristatic Nasal Dressing Summary page 5 …Balloon (21 CFR 874.4100) Regulatory Class: I Product Code: EMX, LYA Predicate Device: Hydrofera Bacteriostatic Nasal Dressing K983276 Reference Devices: PosiSep®/PosiSep® X K122494 Hydrofera Blue Re…	Hydrofera, LLC	1999	—
†	K122494	Posisep and Posisep X Hemostat Dressing/Intranasal Splint	Hemostasis, LLC	2013	—
†	K190268	Hydrofera Blue READY - Border	Hydrofera, LLC	2019	—

Also cleared against K983276: 1 other device →

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?

Its one ancestor has no recall.
1 other device also cites its predicate K983276.

How does its category compare?

All EMX devices

EMX Balloon, Epistaxis: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.

FDA decisions per year · EMX

1in 2022

2007high 1 (2022) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · EMX

Too few EMX 510(k)s in any year since 2007 to give a median.

Recalls per year · EMX

No recall names EMX since 2007.

Adverse event reports per year · EMX

16in 2025

2007high 16 (2025) · low 0 (2015)2025

MAUDE reports naming product code EMX, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	3
2008	0	—	3
2009	0	—	3
2010	0	—	3
2011	0	—	10
2012	0	—	1
2013	0	—	3
2014	0	—	1
2015	0	—	0
2016	0	—	1
2017	0	—	0
2018	0	—	3
2019	0	—	12
2020	0	—	5
2021	0	—	2
2022	1	—	0
2023	0	—	3
2024	0	—	12
2025	0	—	16
2026	0	—	—

What is it indicated for?

PosiSep® X BAM Hemostat Dressing/Intranasal Splint is 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…

Read the full statement (115 words)

PosiSep® X BAM Hemostat Dressing/Intranasal Splint is 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; and

* Act as an adjunct to aid in the natural healing process

PosiSep® X BAM is indicated for use as a nasal hemostat to treat epistaxis.

PosiSep® X BAM is 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/K220326 · printed Nov 6, 2026

Cite this page

510(k) Report. “K220326: PosiSep X BAM 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/K220326

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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