Sterilucent, Inc.: FDA clearances and approvals
Sterilucent, Inc. has 7 FDA 510(k) clearances (first 2014, latest 2019), across 4 product codes in 1 review panel. Median 510(k) review time: 169 days. Since 2017 its median was 88 days, against 120 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2014 | 3 | 174 |
| 2015 | 1 | 169 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 3 | 88 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Sterilucent, Inc.'s cleared 510(k)s took a median 88 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 120 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FRC | Indicator, Biological Sterilization Process | 3 | 3 |
| MLR | Sterilizer, Chemical | 2 | 2 |
| JOJ | Indicator, Physical/Chemical Sterilization Process | 1 | 1 |
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | 1 | 1 |
Review panels
- General Hospital (7)
Most recent Sterilucent, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K192001 | Sterilucent self-Contained Biological Indicator, Sterilucent Lumen Cycle Process Challenge Device, Sterilucent Flexible Cycle Process Challenge Device | FRC | 2019-10-22 | 88 |
| K191999 | Sterilucent VH2O2 Chemical Indicators | JOJ | 2019-10-21 | 87 |
| K190005 | Sterilucent HC 80TT Hydrogen Peroxide Sterilizer | MLR | 2019-09-13 | 254 |
| K142109 | STERILUCENT STERILIZATION CONTAINER SYSTEM | KCT | 2015-01-20 | 169 |
| K141238 | STERILUCENT SELF-CONTAINED BIOLOGICAL INDICATOR | FRC | 2014-11-03 | 174 |
| K141312 | STERILUCENT PROCESS CHALLENGE DEVICE | FRC | 2014-10-31 | 164 |
| K140464 | STERILUCENT PSD-85 HYDROGEN PEROXIDE STERILIZER | MLR | 2014-10-31 | 249 |
Recalls
openFDA lists no recalls under a recalling firm named Sterilucent, 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 Sterilucent, Inc. have?
Sterilucent, Inc. has 7 FDA 510(k) clearances (first 2014, latest 2019), across 4 product codes in 1 review panel.
How long does FDA take to clear Sterilucent, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Sterilucent, Inc.'s cleared 510(k)s is 169 days. Since 2017: 88 days, versus 120 days for all cleared 510(k)s in the same product codes.
What devices does Sterilucent, Inc. make?
Its most frequent FDA product codes are FRC (Indicator, Biological Sterilization Process, 3); MLR (Sterilizer, Chemical, 2); JOJ (Indicator, Physical/Chemical Sterilization Process, 1).
Has Sterilucent, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Sterilucent, Inc. Related entities may recall under other names.
Next steps
- See all 7 Sterilucent, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FRC, Sterilucent, 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.