# K001148: Merogel Otologic Pack

- Pathway: 510(k) (Traditional)
- Applicant: Xomed, Inc.
- Decided: Jun 3, 2000 after 54 days
- Product code: KHJ (Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material))
- Device class: 2
- Regulation: 21 CFR 874.3620
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
18 later devices descend from it; 4 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K043035: Sepragel Ent Bioresorbable Packing/Stent (2005), 10 descendants of its own
- K113585: Nasal/Epistaxis Pack (2012), 7 descendants of its own
- K040501: DBX Demineralized Bone Matrix Putty, Paste and Mix (2005), 3 descendants of its own
- K150594: Biodesign Otologic Repair Graft (2015), 2 descendants of its own
- K141704: Novashield Injectable Nasal Packing and Stent (2014), 2 descendants of its own

Source page: https://510kreport.com/device/K001148
Methodology: https://510kreport.com/methodology