FDA product code · General Hospital
JOJIndicator, Physical/Chemical Sterilization Process
Product code JOJ covers Indicator, Physical/Chemical Sterilization Process, a Class II device regulated under 21 CFR 880.2800. FDA has cleared 264 devices in this code, 2 of them in the last 12 months. Median review time across the 264 most recent decisions is 113 days. openFDA lists 24 recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 880.2800
- Review panel
- General Hospital
- Clearances
- 264
What is happening in JOJ right now?
JOJ (Indicator, Physical/Chemical Sterilization Process) has two findings, most consequential first. 2 first-time filers in the last 12 months, Intertape Polymer Group and Shenzhen Safesecure Medical Infection Control Tech Co. , Ltd (K260181, K251991). The code is crowded, scoring 68 of 100 — 75 companies hold a clearance here and 2 arrived in the last 12 months (JOJ:crowding).
| Finding | How much it matters | FDA records |
|---|---|---|
| New entrant | Worth knowing | K260181, K251991 |
| Crowding | Context | JOJ:crowding |
Sources checked: predicate ancestry, recalls, adverse events, new entrants, review time, crowding. Composed . Every finding carries the record ids it was derived from; nothing here is an estimate.
How many devices has FDA cleared in JOJ?
FDA has cleared 264 devices under product code JOJ since the 510(k) programme began in 1976, 2 of them in the last 12 months.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260181 | LF Process Indicator Tape for Steam Sterilization | Intertape Polymer Group | |
| K251991 | SafeSecure Steam Sterilization Process Indicator (4012, 4013, 4014, 4016); SafeSecure Vaporized Hydrogen Peroxide Sterilization Process Indicator (4211, 4212, 4213) | Shenzhen Safesecure Medical Infection Control Tech Co. , Ltd. | |
| K251035 | DISINTEK PA Test Strips | Serim Research | |
| K251048 | Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118 | STERIS Corporation | |
| K243876 | VERIFY STEAM Integrating Indicator | STERIS Corporation | |
| K250172 | Green Card Bowie-Dick Test (BD115) | Steritec Products, Inc. (A Getinge Company) | |
| K242860 | Type 5 Integrating Indicator for Steam (CSPN-15) | True Indicating, LLC | |
| K241036 | Autoclave Indicator Tape; EO Indicator Tape | Jiangmen New Era External Use Drug Co., Ltd. | |
| K243475 | Chemical Indicator for enspire CLCSPS (LCC015) | STERIS Corporation | |
| K242795 | Getinge Assured MI Steam Migrating Integrator | Steritec Products Mfg. (A Getinge Group Company) |
How long does FDA review take for JOJ?
The median FDA review time for JOJ is 113 days, measured across the 264 most recent decisions with both a received date and a decision date.
Review time here is decision date minus date received, as published by FDA. It is elapsed calendar time, not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Are there recalls in JOJ?
openFDA lists 24 recall records against product code JOJ. A recall record covers one firm's corrective action and may span many device lots.
Z-0836-2024Open, ClassifiedTERRAGENE S.A.
Due to a discrepancy between the FDA-Cleared Indications for Use (IFU) and the actual IFU distributed with the products.
Z-1609-2023Open, Classified3M Company - Health Care Business
3M Attest Steam Chemical Integrators with dates of manufacture between November 6, 2022 and January 17, 2023 have an increased potential to leak ink during a sterilization cycle.
Z-1610-2023Open, Classified3M Company - Health Care Business
3M Attest Steam Chemical Integrators with dates of manufacture between November 6, 2022 and January 17, 2023 have an increased potential to leak ink during a sterilization cycle.
Z-1736-2022TerminatedSteris Corporation Hopkins Facility
Product contains incorrect chemical indicators in packaging.
Z-1792-2022Open, ClassifiedMckesson Medical-Surgical Inc. Corporate Office
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.
Showing the 5 most recently initiated of 24. Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Status is FDA's own wording; a terminated recall is a closed one, and the total spans the code's whole history, not just what is open today.
Source: openFDA device/recall · retrieved
How many adverse events are reported for JOJ?
MAUDE holds 80 adverse-event reports naming product code JOJ, 14 of them received in the last 12 months.
MAUDE reports are submitted by manufacturers, importers, user facilities and the public. They are unverified, and a report is not proof that the device caused the event.
Source: openFDA device/event · retrieved
Is adverse-event reporting in JOJ unusual?
JOJ does not yet have twelve months of adverse-event history in our data, so there is no expected range to compare against. That is a gap in what we hold, not a statement about the device.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 23 | Insufficient history | No expected range — too little history | |
| 3 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 3 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 10 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 4 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 3 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 3 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 8 | Insufficient history | No expected range — too little history |
26 months do not have a full, unbroken year of history before them, so no expected range is shown for those. Insufficient history is reported as insufficient rather than as zero: an empty baseline would turn a gap in our data into a spike.
Who has entered JOJ in the last year?
2 companies filed in JOJ for the first time in the last 12 months.
| Company | First cleared | K-number |
|---|---|---|
| Intertape Polymer Group | K260181 | |
| Shenzhen Safesecure Medical Infection Control Tech Co. , Ltd. | K251991 |
"First time" means their first clearance in this product code, not their first ever — an established manufacturer entering a new category is exactly the movement worth knowing about.
Source: openFDA device/510k · retrieved
What are the predicate devices in JOJ?
FDA publishes no machine-readable predicate field, so no predicate chain is recorded for this code yet.
A predicate chain matters because a device inherits the safety history of what it was compared to. FDA publishes the chain only inside each 510(k) summary PDF, never as data — so where we have edges, they are read from those documents, and where we do not, we say so instead of showing an empty list.
Who files 510(k)s in JOJ?
Across the 264 most recent decisions, these applicants filed most often in JOJ.
| Applicant | Recent clearances |
|---|---|
| STERIS Corporation | 36 |
| 3M Company | 24 |
| Spsmedical Supply Corp. | 17 |
| Albert Browne , Ltd. | 16 |
| Steritec Products Mfg Co, Inc. | 16 |
Applicant names above are exactly as FDA published them, so one company can appear under several spellings.
The same makers, after name resolution
One company in JOJ files under more than one spelling. Resolving them to one identity — across all six datasets, not just this one — is what makes a joined count possible at all.
| Company | Clearances | FDA spellings merged |
|---|---|---|
| Steris Corporation | 42 | 2 |
Merges are measured against a hand-labelled sample and held above 98% precision; pairs the matcher is unsure of are queued for a person rather than merged. See DeviceSignal.
Source: openFDA device/510k · retrieved
Watch JOJ
Get an email the morning anything changes in JOJ — a new clearance, a recall, or an adverse-event spike above this code's own baseline.
Related product codes in General Hospital
Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.