Molnlycke Health Care, Inc.: FDA filings under this applicant name
FDA lists 19 510(k) clearances under the applicant name “Molnlycke Health Care, Inc.” (first 1998, latest 2014), across 10 product codes in 2 review panels. Median 510(k) review time under this name: 86 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 | 2 | 146 |
| 2014 | 2 | 392 |
| 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 |
|---|---|---|---|
| FRO | Dressing, Wound, Drug | 4 | 4 |
| FYA | Gown, Surgical | 3 | 3 |
| KKX | Drape, Surgical, Antimicrobial | 3 | 3 |
| MGP | Dressing, Wound And Burn, Occlusive | 2 | 2 |
| MGQ | Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic | 2 | 2 |
| KMF | Bandage, Liquid | 1 | 1 |
| LZA | Polymer Patient Examination Glove | 1 | 1 |
| MSH | Respirator, Surgical | 1 | 1 |
| OMP | Negative Pressure Wound Therapy Powered Suction Pump | 1 | 1 |
| OXJ | Mesh, Surgical, Non-Absorbable, Large Abdominal Wall Defects | 1 | 1 |
Review panels
Most recent Molnlycke Health Care, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K130852 | AVANCE® FOAM ABDOMINAL DRESSING KIT | OXJ | 2014-04-14 | 382 |
| K130040 | MEPITEL AG | FRO | 2014-02-12 | 401 |
| K123892 | MEPILEX TRANSFER AG | FRO | 2013-04-05 | 108 |
| K122132 | AVANCE FOAM DRESSING KIT INCL. TRANSPARENT FILM, TRANSFER PAD (SMALL, MEDIUM, LARGE) AVANCE TRANSPARENT FILM AVANCE FOAM | OMP | 2013-01-17 | 183 |
| K102923 | BARRIER N95 PARTICULATE RESPIRATOR | MSH | 2010-11-19 | 49 |
| K100029 | MEPILEX BORDER AG DRESSING | FRO | 2010-09-15 | 252 |
| K061554 | MEPILEX AG ABSORBENT SILICONE-COATED DRESSING | FRO | 2007-01-25 | 234 |
| K062138 | POWDER FREE STERILE NITRILE EXAMINATION GLOVES, BLUE; POWDER FREE POLYCHLOROPRENE STERILE EXAMINATION GLOVE | LZA | 2006-10-05 | 71 |
| K051625 | BARRIER SURGICAL DRAPES | KKX | 2005-07-14 | 24 |
| K050786 | BARRIER SURGICAL GOWNS | FYA | 2005-05-09 | 42 |
9 earlier clearances. See the full list in Caduvo.
Recalls
6 product recalls in 5 recall events; 0 initiated in the last five years. Most recent: 2019-03-26.
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Molnlycke Health Care Us, LLC (27 510(k)s)
- Molnlycke A/S Hospital Products (3 510(k)s)
- Molnlycke Clinical Products AB (1 510(k)s)
- Molnlycke Health Care USA (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Molnlycke Health Care, Inc.?
FDA lists 19 510(k) clearances under the applicant name “Molnlycke Health Care, Inc.” (first 1998, latest 2014), across 10 product codes in 2 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 Molnlycke Health Care, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Molnlycke Health Care, Inc. is 86 days.
Which FDA product codes appear under Molnlycke Health Care, Inc.?
The most frequent FDA product codes under this applicant name are FRO (Dressing, Wound, Drug, 4); FYA (Gown, Surgical, 3); KKX (Drape, Surgical, Antimicrobial, 3).
Next steps
- See all 19 Molnlycke Health Care, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FRO, Molnlycke Health Care, Inc.'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.