Steritec Products Mfg Co, Inc.: FDA filings under this applicant name
FDA lists 22 510(k) clearances under the applicant name “Steritec Products Mfg Co, Inc.” (first 1996, latest 2020), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 168 days. 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 | 1 | 112 |
| 2013 | 2 | 168 |
| 2014 | 2 | 290 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 1 | 108 |
| 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 Steritec Products Mfg Co, Inc. took a median 108 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 99 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JOJ | Indicator, Physical/Chemical Sterilization Process | 16 | 16 |
| FRC | Indicator, Biological Sterilization Process | 5 | 5 |
| LRT | Indicator, Sterilization | 1 | 1 |
Review panels
- General Hospital (22)
Most recent Steritec Products Mfg Co, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K200252 | Getinge Assured MI Steam Migrating Integrator | JOJ | 2020-05-21 | 108 |
| K133549 | STERITEC BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR | FRC | 2014-08-27 | 281 |
| K133322 | STERITEC SMART-READ BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR | FRC | 2014-08-25 | 300 |
| K132372 | STERITEC GREEN CARD PACK BOWIE-DICK TEST | JOJ | 2013-11-26 | 119 |
| K122945 | STERITEC GREEN CARD PACK BOWIE-DICK TEST MODEL BD 126 | JOJ | 2013-04-30 | 218 |
| K122555 | STERITEC LEAD FREE STERILIZATION PROCESS INDICATOR TAPE | JOJ | 2012-12-12 | 112 |
| K111150 | STERITEC SMART-READ BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR | FRC | 2011-07-08 | 74 |
| K103000 | SMART READ BIOLOGICAL TEST PACK | JOJ | 2011-02-11 | 126 |
| K072408 | EMU-GRAPH EMULATOR, MODEL CI 131 | JOJ | 2008-04-30 | 247 |
| K000502 | STEAM/EO RECORD CARD, MODEL CI 121 | JOJ | 2000-03-14 | 28 |
12 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Steritec Products Mfg Co, Inc..
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.
- Steritec Products, Inc. (13 510(k)s)
- Steritec Products, Inc. (A Getinge Company) (1 510(k)s)
- Steritec Products Mfg. (A Getinge Group Company) (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Steritec Products Mfg Co, Inc.?
FDA lists 22 510(k) clearances under the applicant name “Steritec Products Mfg Co, Inc.” (first 1996, latest 2020), across 3 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 Steritec Products Mfg Co, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Steritec Products Mfg Co, Inc. is 168 days.
Which FDA product codes appear under Steritec Products Mfg Co, Inc.?
The most frequent FDA product codes under this applicant name are JOJ (Indicator, Physical/Chemical Sterilization Process, 16); FRC (Indicator, Biological Sterilization Process, 5); LRT (Indicator, Sterilization, 1).
Next steps
- See all 22 Steritec Products Mfg Co, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JOJ, Steritec Products Mfg Co, Inc.'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.