510(k) · Cleared
ClearedRhinocell Nasal Packings
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Medical Products, Inc. · EMX Balloon, Epistaxis
Cleared on Aug 4, 1997 after a 34-day review. The FDA summary names its predicate without a number. 32 later devices descend from it.
- Decided
- Aug 4, 1997
- Review
- 34 days
- Class
- Class I
- Product code
- EMX
- Recalls
- None
- Predicates
- 0
32 later devices descend from it, 2 citing it directly.
- This deviceK972459 Rhinocell Nasal PackingsBoston Medical Products, Inc. · 1997
- Descendant · cites it directly · 29 of its ownK033666 HemadermMedafor, Inc. · 2003
- Descendant · 2 generations on · 28 of its ownK070211 Traumarrest and Bleedarrest Hemostatic Particles and FoamHemostasis, LLC · 2007
- Descendant · 3 generations on · 19 of its ownK072900 Excelarrest FoamHemostasis, LLC · 2007
- Descendant · 2 generations on · 11 of its ownK080818 Hemcon Bandage, Hemcon Bandage Otc, Hemcon Chitoflex-Surgical DressingHem Con Medical Technologies, Inc. · 2008
- Descendant · 2 generations on · 9 of its ownK102459 Nexstat (TM) Topical Hemostat Powder; Nexfoam (R) Topical SpongeHemostasis, LLC · 2010
Showing 5 of 32 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 32 · See all- K033666HemadermMedafor, Inc. · 2003 · cites it directly29descendants
- K070211Traumarrest and Bleedarrest Hemostatic Particles and FoamHemostasis, LLC · 2007 · 2 generations on28descendants
- K072900Excelarrest FoamHemostasis, LLC · 2007 · 3 generations on19descendants
- K080818Hemcon Bandage, Hemcon Bandage Otc, Hemcon Chitoflex-Surgical DressingHem Con Medical Technologies, Inc. · 2008 · 2 generations on11descendants
- K102459Nexstat (TM) Topical Hemostat Powder; Nexfoam (R) Topical SpongeHemostasis, LLC · 2010 · 2 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K972459 | Rhinocell Nasal Packings | Boston Medical Products, Inc. | 1997 | — |
| +1 | K033666 | Hemaderm | Medafor, Inc. | 2003 | — |
| +2 | K070211 | Traumarrest and Bleedarrest Hemostatic Particles and Foam | Hemostasis, LLC | 2007 | — |
| +3 | K072900 | Excelarrest Foam | Hemostasis, LLC | 2007 | — |
| +2 | K080818 | Hemcon Bandage, Hemcon Bandage Otc, Hemcon Chitoflex-Surgical Dressing | Hem Con Medical Technologies, Inc. | 2008 | — |
| +2 | K102459 | Nexstat (TM) Topical Hemostat Powder; Nexfoam (R) Topical Sponge | Hemostasis, LLC | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 2 | 0 |
| 2014 | 5 | 0 |
| 2015 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 3 | 0 |
| 2019 | 4 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 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 4.4 · 1 generation · no Class I recall
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 |
|---|---|---|---|
| * | — | Product Nos. Q600314 - Q603113 manufactured by M-Pact Named without a submission number |
What descends from it? (32)
See all 322 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?
- Of its descendants, K033666 (Medafor, Inc., 2003) has gone furthest, with 29 descendants of its own.
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?
For use as a nasal packing to treat epistaxis.
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/K972459 · printed Nov 4, 2026
Cite this page
510(k) Report. “K972459: Rhinocell Nasal Packings.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K972459
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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