FDA product code JOJ: Indicator, Physical/Chemical Sterilization Process
JOJ is the FDA product code for indicator, physical/chemical sterilization process. It is a Class II device, regulated under 21 CFR 880.2800 and reviewed by the General Hospital panel. FDA has cleared 264 510(k) submissions under JOJ, 30 in the last five years, from 80 different applicants. The average 510(k) review took 152 days (median 116); 74 days on average over the last three years. FDA has posted 24 recalls for JOJ devices, 7 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Indicator, Physical/Chemical Sterilization Process |
| Device class | Class II |
| Regulation | 21 CFR 880.2800 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for JOJ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 7 | 180 |
| 2018 | 5 | 148 |
| 2019 | 12 | 79 |
| 2020 | 7 | 125 |
| 2021 | 4 | 196 |
| 2022 | 8 | 120 |
| 2023 | 4 | 67 |
| 2024 | 11 | 101 |
| 2025 | 6 | 91 |
| 2026 | 1 | 30 |
Compare with all 510(k) review times · Search every JOJ clearance
Top JOJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| STERIS Corporation | 36 | 2025-05-02 |
| 3M Company | 24 | 2022-11-01 |
| Spsmedical Supply Corp. | 17 | 2013-07-05 |
| Steritec Products Mfg Co, Inc. | 16 | 2020-05-21 |
| Albert Browne , Ltd. | 16 | 2007-01-12 |
75 more applicants have JOJ clearances. See the full list in Caduvo.
Most recent JOJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K260181 | Intertape Polymer Group | LF Process Indicator Tape for Steam Sterilization | 2026-02-20 | 30 |
| K251991 | Shenzhen Safesecure Medical Infection Control Tech Co. , Ltd. | SafeSecure Steam Sterilization Process Indicator (4012, 4013, 4014, 4016); SafeSecure Vaporized Hydrogen Peroxide Sterilization Process Indicator (4211, 4212, 4213) | 2025-12-23 | 179 |
| K251035 | Serim Research | DISINTEK PA Test Strips | 2025-06-03 | 61 |
| K251048 | STERIS Corporation | Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118 | 2025-05-02 | 29 |
| K243876 | STERIS Corporation | VERIFY STEAM Integrating Indicator | 2025-04-25 | 128 |
Recalls for JOJ devices
24 product recalls in 17 recall events; 7 initiated in the last five years and 6 still open. Most recent: 2023-12-07.
| Year | Recalls |
|---|---|
| 2020 | 1 |
| 2021 | 1 |
| 2022 | 3 |
| 2023 | 3 |
Frequently asked questions
What is FDA product code JOJ?
JOJ is the FDA product code for indicator, physical/chemical sterilization process. It is a Class II device, regulated under 21 CFR 880.2800 and reviewed by the General Hospital panel.
What device class is JOJ?
Class II, regulation 21 CFR 880.2800. Typical premarket route: 510(k).
How long does a 510(k) take for product code JOJ?
Across 264 cleared submissions the average was 152 days from receipt to decision (median 116).
Which companies have the most JOJ clearances?
STERIS Corporation (36); 3M Company (24); Spsmedical Supply Corp. (17); Steritec Products Mfg Co, Inc. (16); Albert Browne , Ltd. (16).
Have JOJ devices been recalled?
Yes: 24 product recalls across 17 recall events; the most recent began 2023-12-07.
Next steps
- Run an FDA pathway report with predicate devices for product code JOJ
- Run a recall and safety report across every JOJ manufacturer
- Watch product code JOJ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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