Medical device manufacturer
Steris Corporation
Steris Corporation holds 224 FDA 510(k) clearances across 35 product codes. Median elapsed review time is 89 days. openFDA lists 142 recall records naming the company. FDA publishes it under 11 different spellings, all counted here as one company.
Updated · ingest status · JSON
- 510(k) clearances
- 224
- Product codes
- 35
- Median review
- 89 days
- Recall records
- 142
How does FDA spell Steris Corporation?
FDA publishes this company under 11 different spellings across its datasets. Every figure on this page counts all of them as one company, which is why the totals here are higher than a search for any single spelling would give you.
| As FDA published it | Dataset | Matched by |
|---|---|---|
| STERIS | device/registrationlisting | normalised |
| STERIS CORPORATION | device/registrationlisting | normalised |
| STERIS Corporation | device/registrationlisting | normalised |
| STERIS Corporation | device/510k | normalised |
| STERIS SPA | device/registrationlisting | normalised |
| Steris | device/510k | normalised |
| Steris C/O Medical Device Consultants, Inc. | device/510k | normalised |
| Steris Corp | device/recall | normalised |
Showing 8 of 11.
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, because two genuinely different firms with similar names is the error that would corrupt every count on this page.
Which product codes does Steris Corporation file in?
35 product codes, ranked by how much they file in each.
| Code | Device | Clearances | Median review | Latest |
|---|---|---|---|---|
| JOJ | Indicator, Physical/Chemical Sterilization Process | 42 | 108 days | |
| FRC | Indicator, Biological Sterilization Process | 35 | 89 days | |
| FLE | Sterilizer, Steam | 23 | 101 days | |
| MED | Sterilant, Medical Devices | 20 | 84 days | |
| MLR | Sterilizer, Chemical | 20 | 117 days | |
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | 11 | 148 days | |
| NZA | Accessories, Germicide, Cleaning, For Endoscopes | 9 | 87 days | |
| FRG | Wrap, Sterilization | 8 | 84 days | |
| ODC | Endoscope Channel Accessory | 7 | 30 days | |
| NVE | Washer, Cleaner, Automated, Endoscope | 5 | 29 days | |
| OWP | Biological Sterilization Process Indicator With Recombinant-Dna Plasmid | 4 | 94 days | |
| PKL | Hemostatic Metal Clip For The Gi Tract | 4 | 28 days | |
| FEB | Accessories, Cleaning, For Endoscope | 3 | 88 days | |
| FGB | Ureteroscope And Accessories, Flexible/Rigid | 3 | 92 days | |
| LGZ | Warmer, Thermal, Infusion Fluid | 3 | 77 days | |
| OVY | Liquid Chemical Processing System | 3 | 88 days | |
| FQO | Table, Operating-Room, Ac-Powered | 2 | 58 days | |
| FST | Light, Surgical, Fiberoptic | 2 | 29 days | |
| GEH | Unit, Cryosurgical, Accessories | 2 | 20 days | |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 2 | 44 days | |
| LRJ | Disinfectant, Medical Devices | 2 | 18 days | |
| DWJ | System, Thermal Regulating | 1 | 110 days | |
| FBK | Endoscopic Injection Needle, Gastroenterology-Urology | 1 | 177 days | |
| FDI | Snare, Flexible | 1 | 29 days | |
| FEQ | Pump, Air, Non-Manual, For Endoscope | 1 | 28 days |
Showing the 25 they file in most, of 35.
Median review is elapsed calendar days between date received and decision date, as published by FDA. It is not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Has Steris Corporation had a recall?
openFDA lists 142 recall records naming this company across its whole history, of which 5 were opened in the last 12 months and are not yet marked terminated. A recall record covers one firm's corrective action and may span many device lots.
Z-2448-2026Class IIOpen, ClassifiedFSY
There is a potential for paint delamination (chipping/peeling) on the lighting system's light heads.
Z-2449-2026Class IIOpen, ClassifiedFSY
The the plus and minus buttons (+/-) used to control light intensity on the light heads may detach.
Z-2450-2026Class IIOpen, ClassifiedFSY
The the plus and minus buttons (+/-) used to control light intensity on the light heads may detach.
Z-0909-2026Class IIOpen, ClassifiedMEC
Wire connected to the electrical box may shift out of its intended position, which may result in electrical arcing. Electrical arcing remains internal within the unit (no risk of shock to users).
Z-0910-2026Class IIOpen, ClassifiedMEC
Wire connected to the electrical box may shift out of its intended position, which may result in electrical arcing. Electrical arcing remains internal within the unit (no risk of shock to users).
Showing the 5 most recently initiated of 142.
Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Recall class I is the most serious kind of recall; device class I is the least risky kind of device, and the two are never mixed here.
Source: openFDA device/recall · retrieved
What has Steris Corporation cleared recently?
| 510(k) | Device | Code | Decision | Elapsed days |
|---|---|---|---|---|
| K261055 | AMSCO 700 Steam Sterilizer | FLE | 85 | |
| K260766 | Celerity 5 HP Biological Indicator (LCB052) | FRC | 30 | |
| K251666 | SYSTEM 1E Liquid Chemical Sterilant Processing System, Model P6700; SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900 | MED | 313 | |
| K252680 | Celerity 20 HP Biological Indicator | FRC | 30 | |
| K251452 | Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045) | FRC | 28 | |
| K251048 | Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118 | JOJ | 29 | |
| K243876 | VERIFY STEAM Integrating Indicator | JOJ | 128 | |
| K250842 | PADLOCK CLIP EFTR Kit (00713229) | PKL | 29 | |
| K242773 | Electro Lube NXT | GEI | 214 | |
| K250061 | Celerity Incubator | FRC | 27 |
Source: openFDA device/510k · retrieved
Where is Steris Corporation registered?
FDA lists 13 registered establishments for this company in US.
Registration means the firm has told FDA it makes or distributes devices from that site. It is not a clearance, an approval or an endorsement.
Watch what Steris Corporation files next
Get an email when this company clears a new device, or when anything is recalled in a product code you follow.
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.