FDA product code · General Hospital · Class 2
JOJ: Indicator, Physical/Chemical Sterilization Process
JOJ is FDA's product code for "Indicator, Physical/Chemical Sterilization Process": a Class 2 device classified under 21 CFR 880.2800, reviewed by the General Hospital panel.
510(k) review time for JOJ
Across 59 510(k) clearances under JOJ decided from 2018-01-01 to 2026-10-06, the median was 87 days from FDA receipt to decision. Half took between 32 and 143 days, and 80% were decided within 153 days. These are past clearances, not a forecast for a new submission.
| Fastest | 17 |
|---|---|
| 25th percentile | 32 |
| Median | 87 |
| 75th percentile | 143 |
| 80th percentile | 153 |
| 90th percentile | 240 |
| Slowest | 546 |
| Year | Median days | n |
|---|---|---|
| 2018 | 150 | 5 |
| 2019 | 38 | 12 |
| 2020 | 108 | 7 |
| 2022 | 90 | 8 |
| 2024 | 71 | 11 |
| 2025 | 90 | 6 |
Source: openFDA 510(k) records, snapshot of 2026-10-06 (openFDA data as of 2026-09-28). Compare 510(k) review times across all device types, see every code side by side in the Clearance Timeline Estimator, or browse the clearances themselves in PredicateScope.
JOJ in the public FDA record
| 510(k) clearances, all years | 264 |
|---|---|
| Device recalls | 24 |
| Establishment listings | 417 |
| GUDID device identifiers | 970 |
Counts of records, not of devices or events. Adverse event reports for JOJ are in MAUDEScope, as counts with the query shown: MAUDE has no denominator, so a report count is not a rate and does not show that a device caused an event.
FDA-recognized standards that cite JOJ
5 FDA recognized consensus standards cite JOJ, 2 of them recognized only in part, among them ISO 11140-5 Second edition 2007-03-15; ISO 15882 Second edition 2008-09-01; ISO 11140-1 Third edition 2014-11-01. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.
- 14-332 ISO 11140-5 Second edition 2007-03-15 — Sterilization of health care products - Chemical indicators - Part 5: Class 2 indicators for Bowie and Dick-type air removal tests
- 14-334 ISO 15882 Second edition 2008-09-01 (partial recognition) — Sterilization of health care products - Chemical indicators - Guidance for selection use and interpretation of results
- 14-460 ISO 11140-1 Third edition 2014-11-01 — Sterilization of health care products - Chemical indicators - Part 1: General requirements
- 14-601 ISO 17665 First edition 2024-03 — Sterilization of health care products - Moist heat - Requirements for the development validation and routine control of a sterilization process for medical devices
- 19-42 IEC 61326-1 Edition 3.0 2020-10 (partial recognition) — Electrical equipment for measurement control and laboratory use - EMC requirements - Part 1: General requirements
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.