510(k) · Cleared
ClearedMerogel Otologic Pack
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Xomed, Inc. · KHJ Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)
Cleared on Jun 3, 2000 after a 54-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 18 later devices descend from it.
- Decided
- Jun 3, 2000
- Review
- 54 days
- Class
- Class II
- Product code
- KHJ
- Recalls
- None
- Predicates
- 0
18 later devices descend from it, 4 citing it directly.
- This deviceK001148 Merogel Otologic PackXomed, Inc. · 2000
- Descendant · cites it directly · 10 of its ownK043035 Sepragel Ent Bioresorbable Packing/StentGenzyme Corporation · 2005
- Descendant · 2 generations on · 7 of its ownK113585 Nasal/Epistaxis PackCogent Therapeutics, LLC · 2012
- Descendant · cites it directly · 3 of its ownK040501 DBX Demineralized Bone Matrix Putty, Paste and MixMusculoskeletal Transplant Foundation · 2005
- Descendant · cites it directly · 2 of its ownK150594 Biodesign Otologic Repair GraftCook Biotech Incorprated · 2015
- Descendant · 3 generations on · 2 of its ownK141704 Novashield Injectable Nasal Packing and StentMedtronic, Inc. · 2014
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K043035Sepragel Ent Bioresorbable Packing/StentGenzyme Corporation · 2005 · cites it directly10descendants
- K113585Nasal/Epistaxis PackCogent Therapeutics, LLC · 2012 · 2 generations on7descendants
- K040501DBX Demineralized Bone Matrix Putty, Paste and MixMusculoskeletal Transplant Foundation · 2005 · cites it directly3descendants
- K150594Biodesign Otologic Repair GraftCook Biotech Incorprated · 2015 · cites it directly2descendants
- K141704Novashield Injectable Nasal Packing and StentMedtronic, Inc. · 2014 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K001148 | Merogel Otologic Pack | Xomed, Inc. | 2000 | — |
| +1 | K043035 | Sepragel Ent Bioresorbable Packing/Stent | Genzyme Corporation | 2005 | — |
| +2 | K113585 | Nasal/Epistaxis Pack | Cogent Therapeutics, LLC | 2012 | — |
| +1 | K040501 | DBX Demineralized Bone Matrix Putty, Paste and Mix | Musculoskeletal Transplant Foundation | 2005 | — |
| +1 | K150594 | Biodesign Otologic Repair Graft | Cook Biotech Incorprated | 2015 | — |
| +3 | K141704 | Novashield Injectable Nasal Packing and Stent | Medtronic, Inc. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 3 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KHJ? 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 KHJ device
- #1 K260266 Tympendi™ (810)score 12.2 · 2 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (18)
See all 184 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, K043035 (Genzyme Corporation, 2005) has gone furthest, with 10 descendants of its own.
How does its category compare?
All KHJ devicesKHJ Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KHJ
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · KHJ
46in 2008
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KHJ
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KHJ
1in 2025
MAUDE reports naming product code KHJ, 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 | 1 | — | 0 | 0 |
| 2008 | 3 | 46 | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 4 |
| 2012 | 2 | — | 0 | 2 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 2 |
| 2015 | 1 | — | 1 | 1 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 4 |
| 2019 | 0 | — | 0 | 2 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 3 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 1 | — | 1 | 0 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 1 | — | 0 | — |
https://510kreport.com/device/K001148 · printed Nov 6, 2026
Cite this page
510(k) Report. “K001148: Merogel Otologic Pack.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K001148
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026