Advanced Sterilization Products: FDA filings under this applicant name
FDA lists 59 510(k) clearances under the applicant name “Advanced Sterilization Products” (first 1994, latest 2026), across 9 product codes in 1 review panel. Median 510(k) review time under this name: 195 days. Since 2017 the median was 196 days, against 128 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 |
|---|---|---|
| 2012 | 8 | 486 |
| 2013 | 0 | — |
| 2014 | 3 | 250 |
| 2015 | 2 | 159 |
| 2016 | 3 | 187 |
| 2017 | 2 | 216 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 1 | 89 |
| 2022 | 1 | 91 |
| 2023 | 0 | — |
| 2024 | 2 | 196 |
| 2025 | 1 | 31 |
| 2026 | 1 | 219 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Advanced Sterilization Products took a median 196 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 128 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FRC | Indicator, Biological Sterilization Process | 17 | 17 |
| MLR | Sterilizer, Chemical | 17 | 17 |
| JOJ | Indicator, Physical/Chemical Sterilization Process | 8 | 8 |
| MED | Sterilant, Medical Devices | 5 | 5 |
| FEB | Accessories, Cleaning, For Endoscope | 4 | 4 |
| FRG | Wrap, Sterilization | 3 | 3 |
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | 3 | 3 |
| FLE | Sterilizer, Steam | 1 | 1 |
| FLF | Sterilizer, Ethylene-Oxide Gas | 1 | 1 |
Review panels
- General Hospital (59)
Most recent Advanced Sterilization Products 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K252843 | STERRAD 100NX Sterilization System with ALLClear Technology (10104) | MLR | 2026-04-15 | 219 |
| K250802 | STERRAD® 100NX Sterilizer with ALLClear Technology (10104) | MLR | 2025-04-14 | 31 |
| K234084 | STERRAD Chemical Indicator (CI) Strip (14100); STERRAD® SEALSURE® Chemical Indicator (CI) Tape (14202NL); STERRAD VELOCITY Biological Indicator (BI) (43210) (60 count); STERRAD VELOCITY Biological Indicator (BI) (43210-30)(30 count); STERRAD VELOCITY Reader (43220); ULTRA GI Process Challenge Device (PCD) (43400)(30 count) | JOJ | 2024-07-05 | 196 |
| K234082 | STERRAD® 100NX Sterilizer with ALLClear Technology and ULTRA GI Cycle (10104); APTIMAX Instrument Tray for ULTRA GI Cycle (011077) | MLR | 2024-07-05 | 196 |
| K220404 | STERRAD NX with ALLClear Technology | MLR | 2022-05-16 | 91 |
| K212174 | STERRAD 100NX Sterilizer with ALLClear Technology | MLR | 2021-10-09 | 89 |
| K163598 | Tyvek Self-Seal Pouches with STERRAD Chemical Indicator, Tyvek Rolls with STERRAD Chemical Indicator, Tyvek Heat-Seal Pouches with STERRAD Chemical Indicator | KCT | 2017-07-31 | 222 |
| K162007 | STERRAD NX Sterilizer | MLR | 2017-02-16 | 211 |
| K160818 | STERRAD® NX Sterilizer with ALLClear Technology | MLR | 2016-09-27 | 187 |
| K160903 | STERRAD 100NX Sterilizer with ALLClearTM Technology | MLR | 2016-09-26 | 178 |
49 earlier clearances. See the full list in Caduvo.
Recalls
69 product recalls in 47 recall events; 0 initiated in the last five years. Most recent: 2017-01-09.
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 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)
- Advanced Spine Fixation Systems, Inc. (16 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Advanced Sterilization Products?
FDA lists 59 510(k) clearances under the applicant name “Advanced Sterilization Products” (first 1994, latest 2026), across 9 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?
The median time from FDA receipt to decision across 510(k)s cleared under the name Advanced Sterilization Products is 195 days. Since 2017: 196 days, versus 128 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Advanced Sterilization Products?
The most frequent FDA product codes under this applicant name are FRC (Indicator, Biological Sterilization Process, 17); MLR (Sterilizer, Chemical, 17); JOJ (Indicator, Physical/Chemical Sterilization Process, 8).
Next steps
- See all 59 Advanced Sterilization Products clearances with predicates and recalls
- Run predicate analysis for product code FRC, Advanced Sterilization Products'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.