510(k) · Cleared
Recalled · Class II · 2025Nasopore Ear
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Polyganics B.V., · NHB Polymer, Ear, Nose And Throat, Synthetic, Absorbable
Cleared on May 7, 2007 as substantially equivalent to K973578 (Invotec International, Inc., 1997) and 1 other predicate after a 54-day review. Its family tree reaches back 3 generations to 1997. 1 later device descends from it. It has been recalled 13 times.
- Decided
- May 7, 2007
- Review
- 54 days
- Class
- Class II
- Product code
- NHB
- Recalls
- 13
- Predicates
- 2
Its longest line of descent runs back 3 generations to K972082 (1997). 7 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK972082 Custom Nasal SplintBoston Medical Products, Inc. · 1997
- 2 generations backK012532 Sepragel SinusGenzyme Corp. · 2001
- 1 generation backK052099 Nasopore Nasal Dressing, Model Ndox-Yyy/ZZPolyganics B.V., · 2005
- This deviceK070715 Nasopore EarPolyganics B.V., · 2007
- Descendant · cites it directly · 0 of its ownK210411 PosiSep EAR Fragmentable Ear DressingHemostasis, LLC · 2022
Most influential descendants
Showing 1 of 1 · See all- K210411PosiSep EAR Fragmentable Ear DressingHemostasis, LLC · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K972082 | Custom Nasal Splint | Boston Medical Products, Inc. | 1997 | — |
| −2 | K012532 | Sepragel Sinus | Genzyme Corp. | 2001 | — |
| −1 | K052099 | Nasopore Nasal Dressing, Model Ndox-Yyy/ZZ | Polyganics B.V., | 2005 | — |
| 0 (this device) | K070715 | Nasopore Ear | Polyganics B.V., | 2007 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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? (2)
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 |
|---|---|---|---|
| * | K973578 | Invotec Ear Tampon (Wick) W/StringSummary page 1…cation Name: ENT synthetic polymer material 21 CFR 874.3620, Class II Predicate - Invotec Ear Tampon (Wick) w/String; Invotec Internat.; K973578 Devices: - Nasopore® nasal dressing, Polyganics, K052099 Performance For the Nasopore® performance, the FDA,… | 1997 |
| * | K052099 | Nasopore Nasal Dressing, Model Ndox-Yyy/ZZSummary page 1….3620, Class II Predicate - Invotec Ear Tampon (Wick) w/String; Invotec Internat.; K973578 Devices: - Nasopore® nasal dressing, Polyganics, K052099 Performance For the Nasopore® performance, the FDA, under section 514 of the Food, Standards Drug and Cosmetic Act,… | 2005 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K210411 | PosiSep EAR Fragmentable Ear Dressing | 2022 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 25, 2025 | Class II | Z-1472-2025 | Under Investigation by firm | There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal has been breached. |
| Feb 25, 2025 | Class II | Z-1471-2025 | Under Investigation by firm | There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal has been breached. |
| Feb 25, 2025 | Class II | Z-1470-2025 | Under Investigation by firm | There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal has been breached. |
| Feb 25, 2025 | Class II | Z-1473-2025 | Under Investigation by firm | There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal has been breached. |
| Feb 25, 2025 | Class II | Z-1478-2025 | Under Investigation by firm | There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal has been breached. |
| Feb 25, 2025 | Class II | Z-1481-2025 | Under Investigation by firm | There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal has been breached. |
| Feb 25, 2025 | Class II | Z-1476-2025 | Under Investigation by firm | There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal has been breached. |
| Feb 25, 2025 | Class II | Z-1469-2025 | Under Investigation by firm | There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal has been breached. |
| Feb 25, 2025 | Class II | Z-1480-2025 | Under Investigation by firm | There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal has been breached. |
| Feb 25, 2025 | Class II | Z-1475-2025 | Under Investigation by firm | There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal has been breached. |
| Feb 25, 2025 | Class II | Z-1479-2025 | Under Investigation by firm | There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal has been breached. |
| Feb 25, 2025 | Class II | Z-1477-2025 | Under Investigation by firm | There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal has been breached. |
| Feb 25, 2025 | Class II | Z-1482-2025 | Under Investigation by firm | There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal has been breached. |
The 5 latest of 13 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 10 years and passes through 3 companies; a new generation was cleared every 4.1 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K210411 (Hemostasis, LLC, 2022) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K973578.
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. 2007, 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?
Nasopore® Ear is a fragmentable ear packing and is indicated for use in patients, undergoing ear surgery, as a space occupying stent to separate and prevent adhesions between mucosal surfaces; to help control minimal bleeding, following ear surgery, by tamponade effect and blood absorption.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070715 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070715: Nasopore Ear.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070715
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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