Andersen Sterilizers, Inc.: FDA clearances and approvals
Andersen Sterilizers, Inc. has 19 FDA 510(k) clearances (first 2015, latest 2022), across 4 product codes in 1 review panel. Median 510(k) review time: 259 days. Since 2017 its median was 261 days, against 115 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2015 | 6 | 206 |
| 2016 | 0 | — |
| 2017 | 6 | 260 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 5 | 275 |
| 2021 | 1 | 156 |
| 2022 | 1 | 193 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Andersen Sterilizers, Inc.'s cleared 510(k)s took a median 261 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 115 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FRG | Wrap, Sterilization | 6 | 6 |
| FRC | Indicator, Biological Sterilization Process | 5 | 5 |
| JOJ | Indicator, Physical/Chemical Sterilization Process | 5 | 5 |
| FLF | Sterilizer, Ethylene-Oxide Gas | 3 | 3 |
Review panels
- General Hospital (19)
Most recent Andersen Sterilizers, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K213296 | Anprolene SteriTest RRBI | FRC | 2022-04-12 | 193 |
| K202879 | EOGas 4 Endo-SteriTest RRBI | FRC | 2021-03-03 | 156 |
| K200336 | Tyvek Sterilization Pouches with Chevron Seal | FRG | 2020-11-12 | 275 |
| K200335 | Sterisheet Sterilization Wrap | FRG | 2020-11-12 | 275 |
| K200334 | AN1036 Dosimeter | JOJ | 2020-11-12 | 275 |
| K192980 | EOGas 4 Endo-SteriTest | FRC | 2020-11-12 | 385 |
| K192978 | EOGas 4 Ethylene Oxide Gas Sterilizer | FLF | 2020-11-12 | 385 |
| K170439 | AN87 Dosimeter | JOJ | 2017-11-01 | 261 |
| K170437 | Sterisheet Sterilization Wrap | FRG | 2017-11-01 | 261 |
| K170432 | Anprolene AN75 Ethylene Oxide Gas Sterilizer | FLF | 2017-10-31 | 260 |
9 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Andersen Sterilizers, Inc..
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 Andersen Sterilizers, Inc. have?
Andersen Sterilizers, Inc. has 19 FDA 510(k) clearances (first 2015, latest 2022), across 4 product codes in 1 review panel.
How long does FDA take to clear Andersen Sterilizers, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Andersen Sterilizers, Inc.'s cleared 510(k)s is 259 days. Since 2017: 261 days, versus 115 days for all cleared 510(k)s in the same product codes.
What devices does Andersen Sterilizers, Inc. make?
Its most frequent FDA product codes are FRG (Wrap, Sterilization, 6); FRC (Indicator, Biological Sterilization Process, 5); JOJ (Indicator, Physical/Chemical Sterilization Process, 5).
Has Andersen Sterilizers, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Andersen Sterilizers, Inc. Related entities may recall under other names.
Next steps
- See all 19 Andersen Sterilizers, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FRG, Andersen Sterilizers, Inc.'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.