Bemis Health Care: FDA clearances and approvals
Bemis Health Care has 12 FDA 510(k) clearances (first 1976, latest 1989), across 9 product codes in 1 review panel. Median 510(k) review time: 32 days. openFDA lists 1 product recall by a recalling firm named Bemis Health Care.
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 |
|---|---|---|---|
| BYZ | Trap, Sterile Specimen | 2 | 2 |
| FNP | Urinal | 1 | 1 |
| FNY | Basin, Emesis | 1 | 1 |
| FOB | Bedpan | 1 | 1 |
| FRG | Wrap, Sterilization | 1 | 1 |
| GCX | Apparatus, Suction, Operating-Room, Wall Vacuum Powered | 1 | 1 |
| JOL | Catheter And Tip, Suction | 1 | 1 |
| LDQ | 1 | 1 |
Plus 1 more product codes.
Review panels
- General Hospital (8)
Most recent Bemis Health Care 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K885019 | BEMIS STERILE-CASE FOR USE W/ETHYLENE OXIDE STERI. | FRG | 1989-01-25 | 57 |
| K822557 | SPECIMEN ADAPTOR | BYZ | 1982-10-18 | 55 |
| K822556 | CRITICAL MEASUREMENT UNIT | BYZ | 1982-10-18 | 55 |
| K803206 | SUCTION PROBE | JOL | 1981-01-21 | 35 |
| K771737 | SUCTION CANISTER | GCX | 1977-12-20 | 96 |
| K771738 | MALE URINAL | FNP | 1977-09-28 | 13 |
| K771733 | 8 EMESIS BASIN | FNY | 1977-09-28 | 13 |
| K760393 | BED PAN, STACKABLE (AUTOCLAVABLE) | FOB | 1976-08-23 | 17 |
| K760073 | BASIN, WASH, 6-QT RECTANGULAR | LDQ | 1976-07-20 | 32 |
| K760072 | CARAFE, PERSONAL, 1-QT SEMI-RECTANGULAR | — | 1976-07-20 | 32 |
2 earlier clearances. See the full list in Caduvo.
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2006-08-23.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Bemis Health Care have?
Bemis Health Care has 12 FDA 510(k) clearances (first 1976, latest 1989), across 9 product codes in 1 review panel.
How long does FDA take to clear Bemis Health Care's 510(k)s?
The median time from FDA receipt to decision across Bemis Health Care's cleared 510(k)s is 32 days.
What devices does Bemis Health Care make?
Its most frequent FDA product codes are BYZ (Trap, Sterile Specimen, 2); FNP (Urinal, 1); FNY (Basin, Emesis, 1).
Has Bemis Health Care had device recalls?
openFDA lists 1 product recall in 1 recall event by a recalling firm whose name matches Bemis Health Care; the most recent began 2006-08-23. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 12 Bemis Health Care clearances with predicates and recalls
- Run predicate analysis for product code BYZ, Bemis Health Care's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.