FDA product code PJJ: Two Or More Sterilant Sterilizer
PJJ is the FDA product code for two or more sterilant sterilizer. It is a Class II device, regulated under 21 CFR 880.6860 and reviewed by the General Hospital panel. FDA has cleared 6 510(k) submissions under PJJ, from 2 different applicants. The average 510(k) review took 182 days (median 176).
Definition
Intended for use in terminal sterilization of cleaned, rinsed, and dried metal and non-metal reusable medical devices in health care facilities.
Classification
| Field | Value |
|---|---|
| Device name | Two Or More Sterilant Sterilizer |
| Device class | Class II |
| Regulation | 21 CFR 880.6860 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) |
510(k) clearances per year for PJJ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 2 | 198 |
| 2019 | 1 | 161 |
Compare with all 510(k) review times · Search every PJJ clearance
Top PJJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Tso3, Inc. | 5 | 2019-07-19 |
| Ts03, Inc. | 1 | 2016-03-24 |
Most recent PJJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K190260 | Tso3, Inc. | STERIZONE(R) VP4 Sterilizer | 2019-07-19 | 161 |
| K172191 | Tso3, Inc. | STERIZONE VP4 Sterilizer | 2018-05-09 | 293 |
| K173694 | Tso3, Inc. | STERIZONE VP4 Sterilizer | 2018-03-13 | 102 |
| K153689 | Tso3, Inc. | STERIZONE Sterilizer | 2016-06-30 | 190 |
| K153392 | Ts03, Inc. | STERIZONE VP4 Sterilizer | 2016-03-24 | 121 |
Recalls for PJJ devices
openFDA lists no recalls for product code PJJ.
Frequently asked questions
What is FDA product code PJJ?
PJJ is the FDA product code for two or more sterilant sterilizer. It is a Class II device, regulated under 21 CFR 880.6860 and reviewed by the General Hospital panel.
What device class is PJJ?
Class II, regulation 21 CFR 880.6860. Typical premarket route: 510(k).
How long does a 510(k) take for product code PJJ?
Across 6 cleared submissions the average was 182 days from receipt to decision (median 176).
Which companies have the most PJJ clearances?
Tso3, Inc. (5); Ts03, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code PJJ
- Run a recall and safety report across every PJJ manufacturer
- Watch product code PJJ 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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