510(k) · Cleared
ClearedIvalon Nasal Packing W/Drawstring (8.0CM & 4.5CM), Ivalon Nasal Packing W/Airway Tube & Drawstring, Ivalon Contour Nasal
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
M-Pact Worldwide Management Corp. · EMX Balloon, Epistaxis
Cleared on Nov 7, 1996 as substantially equivalent to K920358 (Ultracell Medical Technologies, Inc., 1992) and 2 other predicates after a 23-day review. Its family tree reaches back 1 generation to 1990.
- Decided
- Nov 7, 1996
- Review
- 23 days
- Class
- Class I
- Product code
- EMX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K900171 (1990). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK900171 Expandacel Nasal TamponsSurgitrend, Ltd. · 1990
- This deviceK964113 Ivalon Nasal Packing W/Drawstring (8.0CM & 4.5CM), Ivalon Nasal…M-Pact Worldwide Management Corp. · 1996
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K900171 | Expandacel Nasal Tampons | Surgitrend, Ltd. | 1990 | — |
| 0 (this device) | K964113 | Ivalon Nasal Packing W/Drawstring (8.0CM & 4.5CM), Ivalon Nasal Packing… | M-Pact Worldwide Management Corp. | 1996 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1992 | 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 EMX? 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 EMX device
- #1 K220326 PosiSep X BAM Hemostat Dressing/Intranasal…score 4.3 · 1 generation · no Class I recall
What was it cleared against? (6)
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 |
|---|---|---|---|
| * | K920358 | Ultracell Nasal PackingSummary page 1…in interstate commerce and which were on the market prior to the date of the enactment of the Medical Device Amendment of 1976 (May 28, 1976) (Ultracell Nasal Packing - K920358, Merocel Nasal Packing - pre-amendment, and the Expandacell Nasal Tapon — K990171, K912524). The M-PACT nasal and sinus packs are… | 1992 |
| * | K900171 | Expandacel Nasal Tampons Our OCR of the scanned summary read K990171, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Expandacell Nasal Tampon”. | 1990 |
| * | K912524 | Expandacel Nasal Tampons, ModificationSummary page 1…the Medical Device Amendment of 1976 (May 28, 1976) (Ultracell Nasal Packing - K920358, Merocel Nasal Packing - pre-amendment, and the Expandacell Nasal Tapon — K990171, K912524). The M-PACT nasal and sinus packs are identical in size, shape, material composition and intended use as the Merocel Nasal Pack… | 1991 |
| * | — | Merocel Nasal Packing Named without a submission number | |
| * | — | Merocel Nasal Pack Named without a submission number | |
| * | — | Kennedy Sinus Pack Named without a submission number |
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?
- 1 of the 3 ancestors has a recall of any class.
How does its category compare?
All EMX devicesEMX Balloon, Epistaxis: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EMX
1in 2022
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
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 | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 3 |
| 2008 | 0 | — | 0 | 3 |
| 2009 | 0 | — | 0 | 3 |
| 2010 | 0 | — | 0 | 3 |
| 2011 | 0 | — | 0 | 10 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 3 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 3 |
| 2019 | 0 | — | 0 | 12 |
| 2020 | 0 | — | 0 | 5 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 3 |
| 2024 | 0 | — | 0 | 12 |
| 2025 | 0 | — | 0 | 16 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Nasal and sinus packings are used to absorb excess body fluids after septal, turbinate, or rhinoplastic surgery or endoscopic sinus surgery, and for the control of epistaxis (i.e., nose bleeds). They are packaged individually as a sterile, dried and compressed sponge that is inserted into the nasal or sinus cavity. When expanded via absorption of blood after insertion, the nasal packing is intended to fill the necessary space to prevent lateral motion of the turbinate and provide gentle pressure on the mucosa. The sinus packing is intended to selectively pack only the ostiomeatal complex leaving the nasal cavity clear for breathing.
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/K964113 · printed Nov 5, 2026
Cite this page
510(k) Report. “K964113: Ivalon Nasal Packing W/Drawstring (8.0CM & 4.5CM), Ivalon Nasal Packing W/Airway Tube & Drawstring, Ivalon Contour Nasal.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K964113
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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