Product code LRT
- Device name
- Indicator, Sterilization
- Medical specialty
- General Hospital
- Device class
- 2
- Regulation number
- 880.2800
- Review panel
- HO
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K002937 | TST CONTROL INTEGRATOR FOR STEAM STERILIZERS | Albert Browne , Ltd. | 2001-11-05 |
| K965154 | TST CONTROL INTEGRATOR FOR STEAM AUTOCLAVE | Albert Browne , Ltd. | 1997-09-19 |
| K951113 | CROSS-CHECKS | Steritec Products Mfg Co, Inc. | 1996-08-19 |
| K951703 | TAMPER EVIDENT ARROWS WITH AND WITHOUT STERILIZATION INDICATORS | Products For Medicine | 1995-06-28 |
| K871672 | STERILIZATION INDICATOR FOR FLASH STERILIZATION | Propper Mfg. Co., Inc. | 1987-06-01 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10818087010952 | "Gas-Chex EO Gas 3/4"" Indicator Tape" | PROPPER MANUFACTURING COMPANY, INC. | 2023-06-16 |
| H816MSM43401 | ProCheck ID | MicroCare, LLC | 2022-10-26 |
| H816MSM43402 | ProCheck ID | MicroCare, LLC | 2022-10-26 |
| 10080196479009 | MEDLINE INDUSTRIES, INC. | MEDLINE INDUSTRIES, INC. | 2022-03-23 |
| 40080196479000 | MEDLINE INDUSTRIES, INC. | MEDLINE INDUSTRIES, INC. | 2022-03-23 |
| 10080196729586 | Medline | MEDLINE INDUSTRIES, INC. | 2021-01-26 |
| 30080196729580 | Medline | MEDLINE INDUSTRIES, INC. | 2021-01-26 |
| 10080196756988 | Medline | MEDLINE INDUSTRIES, INC. | 2021-01-02 |
| 30080196756982 | Medline | MEDLINE INDUSTRIES, INC. | 2021-01-02 |
| 20080196756992 | Medline | MEDLINE INDUSTRIES, INC. | 2020-12-31 |
| 10080196756995 | Medline | MEDLINE INDUSTRIES, INC. | 2020-12-31 |
| 70818087013412 | "Propper 1"" Gas-Chex Sterilization Tape" | PROPPER MANUFACTURING COMPANY, INC. | 2020-03-04 |
| 10818087013410 | Propper 1" Gas-Chex Sterilization Tape | PROPPER MANUFACTURING COMPANY, INC. | 2020-03-04 |
| 00814434021209 | Getinge Assured Steam Sterilization Indicator | STERITEC PRODUCT MFG. CO., INC. | 2019-06-10 |
| 00814434021193 | Getinge Assured Steam Sterilization Indicator | STERITEC PRODUCT MFG. CO., INC. | 2019-06-10 |
| 20814434021197 | Getinge Assured Steam Sterilization Indicator | STERITEC PRODUCT MFG. CO., INC. | 2019-06-10 |
| 20814434021203 | Getinge Assured Steam Sterilization Indicator | STERITEC PRODUCT MFG. CO., INC. | 2019-06-10 |
| H816PIT3401 | ProChek ID | CERTOL INTERNATIONAL, LLC | 2017-01-13 |
| 50885380112520 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2016-09-23 |
| 50885380112148 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2016-09-23 |
| H816SM43402 | ProChek ID | CERTOL INTERNATIONAL, LLC | 2016-09-23 |
| H816PIT1201 | ProChek ID | CERTOL INTERNATIONAL, LLC | 2016-09-23 |
| H816PIT1002 | ProChek ID | CERTOL INTERNATIONAL, LLC | 2016-09-23 |
| 20885380112529 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2016-09-23 |
| 20885380112147 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2016-09-23 |
| H816SM43401 | ProChek ID | CERTOL INTERNATIONAL, LLC | 2016-09-23 |
| H816PIT1001 | ProChek ID | CERTOL INTERNATIONAL, LLC | 2016-09-23 |
| 20809160002527 | Medical Action Industries | MEDICAL ACTION INDUSTRIES INC. | 2016-08-20 |
| 30809160002524 | Medical Action Industries | MEDICAL ACTION INDUSTRIES INC. | 2016-08-20 |
| 17540196000625 | Sterilization Monitors, Steam | Scican Ltd | 2016-08-02 |