Bemis Mfg. Co.: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “Bemis Mfg. Co.” (first 1985, latest 2002), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 98 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 |
|---|---|---|---|
| MMK | Container, Sharps | 7 | 7 |
| FMI | Needle, Hypodermic, Single Lumen | 2 | 2 |
| FRG | Wrap, Sterilization | 1 | 1 |
| GCX | Apparatus, Suction, Operating-Room, Wall Vacuum Powered | 1 | 1 |
| KPE | Container, I.V. | 1 | 1 |
Review panels
- General Hospital (12)
Most recent Bemis Mfg. Co. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K020921 | NO-POKES NEEDLE SAFETY DEVICE | FMI | 2002-07-11 | 112 |
| K965248 | BEMIS TWO GALLON SHARPS CONTAINER | FMI | 1997-02-14 | 72 |
| K964858 | BEMIS TWO GALLON CHEMOTHERAPY CONTAINER | MMK | 1997-02-11 | 69 |
| K960525 | BEMIS ONE QUART PHLEBOTOMY CONTAINER (PART NUMBER 100) | MMK | 1996-03-28 | 52 |
| K953797 | SHARPS DISPOSAL CONTAINERS | MMK | 1995-11-27 | 108 |
| K950340 | IGHT AND ELEVEN GALLON SHARPS AND CHEMOTHERAPY CONTAINERS | MMK | 1995-06-02 | 126 |
| K941665 | SHARPS DISPOSAL CONTAINER/PHLEBOTOMY | MMK | 1994-05-23 | 77 |
| K941664 | SHARP DISPOSAL CONTAINERS WALL SAFE | MMK | 1994-05-23 | 77 |
| K931664 | SHARPS DISPOSABLE CONTAINERS | MMK | 1994-05-23 | 413 |
| K914601 | SUCTION CONNECTING TUBING | GCX | 1992-02-07 | 119 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Bemis Mfg. Co..
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.
- Bemis Health Care (12 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Bemis Mfg. Co.?
FDA lists 12 510(k) clearances under the applicant name “Bemis Mfg. Co.” (first 1985, latest 2002), across 5 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Bemis Mfg. Co.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Bemis Mfg. Co. is 98 days.
Which FDA product codes appear under Bemis Mfg. Co.?
The most frequent FDA product codes under this applicant name are MMK (Container, Sharps, 7); FMI (Needle, Hypodermic, Single Lumen, 2); FRG (Wrap, Sterilization, 1).
Next steps
- See all 12 Bemis Mfg. Co. clearances with predicates and recalls
- Run predicate analysis for product code MMK, Bemis Mfg. Co.'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.