Molnlycke Health Care Us, LLC: FDA filings under this applicant name
FDA lists 27 510(k) clearances under the applicant name “Molnlycke Health Care Us, LLC” (first 2006, latest 2023), across 5 product codes in 3 review panels. Median 510(k) review time under this name: 116 days. Since 2017 the median was 122 days, against 197 days for all cleared 510(k)s in the same product codes. 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 | 1 | 255 |
| 2013 | 1 | 127 |
| 2014 | 1 | 71 |
| 2015 | 4 | 240 |
| 2016 | 6 | 117 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 1 | 128 |
| 2020 | 3 | 117 |
| 2021 | 1 | 227 |
| 2022 | 0 | — |
| 2023 | 1 | 28 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Molnlycke Health Care Us, LLC took a median 122 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 197 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KGO | Surgeon'S Gloves | 16 | 16 |
| OMP | Negative Pressure Wound Therapy Powered Suction Pump | 7 | 7 |
| DWJ | System, Thermal Regulating | 2 | 2 |
| FRO | Dressing, Wound, Drug | 1 | 1 |
| OXJ | Mesh, Surgical, Non-Absorbable, Large Abdominal Wall Defects | 1 | 1 |
Review panels
Most recent Molnlycke Health Care Us, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K232508 | Barrier EasyWarm Active Self-Warming Blanket | DWJ | 2023-09-15 | 28 |
| K203369 | Avance Solo Negative Pressure Wound Therapy (NPWT) System | OMP | 2021-07-01 | 227 |
| K202090 | Biogel Eclipse / Biogel Eclipse Indicator Underglove, Biogel Surgeons / Biogel Indicator Underglove, Biogel PI Micro Indicator Underglove, Biogel PI UltraTouch S Surgical Glove with a Low Dermatitis Potential Claim, Biogel PI UltraTouch S Indicator Underglove with a Low Dermatitis Potential Claim | KGO | 2020-11-22 | 117 |
| K193573 | Biogel Skinsense Indicator Underglove, Biogel PI Ultratouch, Biogel PI Indicator Underglove, Biogel PI, Biogel PI Micro | KGO | 2020-04-10 | 109 |
| K191869 | Biogel(R) PI UltraTouch S Surgical Glove with a Low Dermatitis Potential Claim, Biogel(R) PI UltraTouch S Indicator Underglove with a Low Dermatitis Potential Claim | KGO | 2020-03-13 | 245 |
| K190077 | Biogel® PI UltraTouch S Surgical Glove, Biogel® Pl Ultra Touch S Indicator Underglove | KGO | 2019-05-24 | 128 |
| K161939 | Avance Abdominal Dressing Kit | OXJ | 2016-11-17 | 126 |
| K161935 | Avance Foam Dressing Kit - XL | OMP | 2016-11-04 | 113 |
| K161948 | Avance Gauze Dressing Kits | OMP | 2016-11-03 | 111 |
| K161797 | Avance Tubing, Avance Y-Connector, Avance ViewPad | OMP | 2016-10-19 | 111 |
17 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Molnlycke Health Care Us, LLC.
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, Inc. (19 510(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)
- Molnlycke/Scott Health Care (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Molnlycke Health Care Us, LLC?
FDA lists 27 510(k) clearances under the applicant name “Molnlycke Health Care Us, LLC” (first 2006, latest 2023), across 5 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 Molnlycke Health Care Us, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Molnlycke Health Care Us, LLC is 116 days. Since 2017: 122 days, versus 197 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Molnlycke Health Care Us, LLC?
The most frequent FDA product codes under this applicant name are KGO (Surgeon'S Gloves, 16); OMP (Negative Pressure Wound Therapy Powered Suction Pump, 7); DWJ (System, Thermal Regulating, 2).
Next steps
- See all 27 Molnlycke Health Care Us, LLC clearances with predicates and recalls
- Run predicate analysis for product code KGO, Molnlycke Health Care Us, LLC'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.