Merocel Corp.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Merocel Corp.” (first 1992, latest 1995), across 6 product codes in 3 review panels. Median 510(k) review time under this name: 87 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KMF | Bandage, Liquid | 3 | 3 |
| EMX | Balloon, Epistaxis | 2 | 2 |
| LYA | Splint, Intranasal Septal | 2 | 2 |
| BTR | Tube, Tracheal (W/Wo Connector) | 1 | 1 |
| EFQ | Gauze/Sponge, Internal | 1 | 1 |
| KHJ | Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material) | 1 | 1 |
Review panels
Most recent Merocel Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K954919 | MEROCEL SOFT WOUND DRESSING | KMF | 1995-11-14 | 19 |
| K953072 | MEROCEL VAGINAL PACK | EFQ | 1995-09-12 | 74 |
| K953013 | MEROCEL REINFORCED SILICONE SHEETS | KHJ | 1995-08-29 | 61 |
| K943718 | EPISTAT-II NASAL CATHETER | EMX | 1994-09-16 | 46 |
| K940572 | MEROCEL(R) WOUND DRESSING (WITH HEMOSTATIC CLAIM) | KMF | 1994-06-07 | 119 |
| K935658 | MEROCEL(R) TURBINATE GLOVE AND SEPTAL SPLINT | LYA | 1994-03-04 | 100 |
| K933152 | MEROCEL MEROSPLINT | LYA | 1993-08-17 | 49 |
| K931565 | MEROCEL WOUND DRESSING | KMF | 1993-08-06 | 129 |
| K920394 | MEROCEL EPISTACIS KIT | EMX | 1993-03-18 | 413 |
| K910463 | MEROCEL(R) LASER-GUARD(TM) | BTR | 1992-04-06 | 437 |
Recalls
openFDA lists no recalls under a recalling firm named Merocel Corp..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Merocel Corp.?
FDA lists 10 510(k) clearances under the applicant name “Merocel Corp.” (first 1992, latest 1995), across 6 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Merocel Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Merocel Corp. is 87 days.
Which FDA product codes appear under Merocel Corp.?
The most frequent FDA product codes under this applicant name are KMF (Bandage, Liquid, 3); EMX (Balloon, Epistaxis, 2); LYA (Splint, Intranasal Septal, 2).
Next steps
- See all 10 Merocel Corp. clearances with predicates and recalls
- Run predicate analysis for product code KMF, Merocel Corp.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.