Advanced Sterilization Products (Asp): FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Advanced Sterilization Products (Asp)” (first 2016, latest 2020), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 178 days. Since 2017 the median was 172 days, against 107 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 |
|---|---|---|
| 2016 | 1 | 350 |
| 2017 | 1 | 166 |
| 2018 | 1 | 114 |
| 2019 | 1 | 323 |
| 2020 | 1 | 178 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Advanced Sterilization Products (Asp) took a median 172 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 107 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FRC | Indicator, Biological Sterilization Process | 3 | 3 |
| FEB | Accessories, Cleaning, For Endoscope | 2 | 2 |
Review panels
- General Hospital (5)
Most recent Advanced Sterilization Products (Asp) 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K192025 | STERRAD VELOCITY Biological Indicator/Process Challenge Device and Reader | FRC | 2020-01-23 | 178 |
| K181472 | AEROFLEX(TM) Automatic Endoscope Reprocessor with AUTOSURE(TM) MRC Monitor | FEB | 2019-04-23 | 323 |
| K182404 | STERRAD VELOCITY Biological Indicator | FRC | 2018-12-27 | 114 |
| K170039 | STERRAD VELOCITY Biological Indictator and Reader | FRC | 2017-06-20 | 166 |
| K152189 | EVOTECH ECR | FEB | 2016-07-20 | 350 |
Recalls
openFDA lists no recalls under a recalling firm named Advanced Sterilization Products (Asp).
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.
- Advanced Cardiovascular Systems, Inc. (103 510(k)s)
- Advanced Surgical Products, Inc. (64 510(k)s)
- Advanced Technology Laboratories, Inc. (61 510(k)s)
- Advanced Sterilization Products (59 510(k)s)
- Advanced Neuromodulation Systems (25 510(k)s)
- Advanced Orthopaedic Solutions, Inc. (24 510(k)s)
- Advanced Biosearch Assn. (22 510(k)s)
- Advanced Biomedical Methods, Inc. (21 510(k)s)
- Advanced Surgical, Inc. (21 510(k)s)
- Advanced Clinical Diagnostics (19 510(k)s)
- Advanced Instrumentations, Inc. (16 510(k)s)
- Advanced Instruments, Inc. (16 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Advanced Sterilization Products (Asp)?
FDA lists 5 510(k) clearances under the applicant name “Advanced Sterilization Products (Asp)” (first 2016, latest 2020), across 2 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 Advanced Sterilization Products (Asp)?
The median time from FDA receipt to decision across 510(k)s cleared under the name Advanced Sterilization Products (Asp) is 178 days. Since 2017: 172 days, versus 107 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Advanced Sterilization Products (Asp)?
The most frequent FDA product codes under this applicant name are FRC (Indicator, Biological Sterilization Process, 3); FEB (Accessories, Cleaning, For Endoscope, 2).
Next steps
- See all 5 Advanced Sterilization Products (Asp) clearances with predicates and recalls
- Run predicate analysis for product code FRC, Advanced Sterilization Products (Asp)'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.