Steritec Products, Inc.: FDA filings under this applicant name
FDA lists 13 510(k) clearances under 2 spellings of the applicant name “Steritec Products, Inc.” (first 2000, latest 2026), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 86 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 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 1 | 272 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Steritec Products, Inc. took a median 272 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 94 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JOJ | Indicator, Physical/Chemical Sterilization Process | 12 | 12 |
| QVB | Biological Sterilization Indicator With Indirect Growth Detection | 1 | 1 |
Review panels
- General Hospital (13)
Most recent Steritec Products, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K252306 | Verrix EVA STEAM Biological Indicator (BI) (Model: 1200), Verrix EVA STEAM Process Challenge Device (PCD) (Model: 1300) combined with Verrix EVA Auto-Reader (Model: 1100) | QVB | 2026-04-22 | 272 |
| K083650 | EMU-GRAPH 4 EMULATOR, MODEL CI 144 | JOJ | 2009-03-05 | 86 |
| K080136 | INSTANT READOUT CHEMICAL INTEGRATOR CHALLENGE PACK, MODEL LT- 105 | JOJ | 2008-08-15 | 206 |
| K052516 | STERITEC CONTAINER CORD - CI 135, STERITEC PROCESS INDICATOR LABELS - CI 140, STERITEC PROCESS INDICATOR DOTS - CI 137 | JOJ | 2005-10-03 | 19 |
| K040901 | STERITEC EMU-GRAPH, MODEL NO. CI 131/US | JOJ | 2004-09-09 | 155 |
| K024293 | BOWIE-DICK MINI PAK, MODEL BD 115 | JOJ | 2003-08-11 | 230 |
| K012732 | INTEGRAPH FLASH, MODEL CI 110 | JOJ | 2002-03-04 | 200 |
| K010534 | CROSS-CHECKS DUAL, MODEL CI 125 | JOJ | 2001-08-06 | 164 |
| K003533 | CROSS-CHECKS LF, MODEL CI 119/S &CI 119/L | JOJ | 2001-02-07 | 83 |
| K003002 | STERILIZATION PROCESS INDICATOR TAPES MODEL CI112 & CI123 | JOJ | 2000-12-08 | 73 |
3 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Steritec Products, 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.
FDA spellings included
FDA records this applicant under 2 spellings (case, punctuation and legal-suffix variants of one name); this page adds them up. Filings per spelling:
- Steritec Products, Inc. (12)
- Steritec Products (1)
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 Mfg Co, Inc. (22 510(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, Inc.?
FDA lists 13 510(k) clearances under 2 spellings of the applicant name “Steritec Products, Inc.” (first 2000, latest 2026), 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 Steritec Products, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Steritec Products, Inc. is 86 days.
Which FDA product codes appear under Steritec Products, Inc.?
The most frequent FDA product codes under this applicant name are JOJ (Indicator, Physical/Chemical Sterilization Process, 12); QVB (Biological Sterilization Indicator With Indirect Growth Detection, 1).
Next steps
- See all 13 Steritec Products, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JOJ, Steritec Products, 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.