Biosign
FDA 510(k) K872867 · Clinical Technology Corp.
510(k) numberK872867
Submission
- Device name
- Biosign
- Applicant
- Clinical Technology Corp.
Rochester, NY, US - Received
- July 21, 1987
- Decision date
- July 6, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FRC – Indicator, Biological Sterilization Process
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.2800
- Specialty
- General Hospital
Other 510(k)s with product code FRC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260766 | Celerity 5 HP Biological Indicator (LCB052)FRC · Special | STERIS Corporation | 04/08/2026SE |
| K252680 | Celerity 20 HP Biological IndicatorFRC · Special | STERIS Corporation | 09/24/2025SE |
| K251122 | Terragene® Bionova® BT20 Biological IndicatorFRC · Traditional | Terragene | 08/04/2025SE |
| K251452 | Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059)…FRC · Special | Steris | 06/06/2025SE |
| K250061 | Celerity IncubatorFRC · Special | STERIS Corporation | 02/06/2025SE |
| K250044 | Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059)…FRC · Special | STERIS Corporation | 02/06/2025SE |
| K243501 | 3M Attest Super Rapid Steam Extended Cycle Clear Challenge Pack 1492PCDE; 3M Attest…FRC · Traditional | 3M Company | 01/28/2025SE |
| K242453 | Terragene® Bionova® Photon Process Challenge Device with unique-point integrator…FRC · Traditional | Terragene S.A. | 12/12/2024SE |
| K242538 | 3M Attest Super Rapid Readout Biological Indicator 1493; 3M Attest Super Rapid Steam…FRC · Traditional | 3M Company | 11/25/2024SE |
| K241959 | 3M Attest Super Rapid Steam Clear Challenge Pack (1492PCD); 3M Attest Auto-reader…FRC · Traditional | 3M Company | 10/18/2024SE |
More from 3M Company
| 510(k) | Device | Decision |
|---|---|---|
| K925080 | Tek-LubeEFB · Traditional | 01/31/1994SE |
| K880166 | Bovie Ultrasonic Surgical Aspirator, Model ME2000LFL · Traditional | 02/18/1988SE |
| K872705 | Bovie 400-CT Electrosurgical Generator (Unit)GEI · Traditional | 09/01/1987SE |
| K855138 | Bovie Ultrasonic Surgical SystemLBK · Traditional | 11/10/1986SE |
| K854231 | Electrosurgical Cutting & Coagulation Device/AccesGEI · Traditional | 05/02/1986SE |
| K853507 | Steri-Grip · Traditional | 09/05/1985SE |
| K852986 | Glyco-Sep/Alc Test Kit for Separat of HemoglobinLCP · Traditional | 08/19/1985SE |
| K844565 | Bovie X-10 Electrosurgical Generator(Unit)GEI · Traditional | 02/21/1985SE |
| K841272 | Sickle-Stat Hemoglobin S Screen KitGHM · Traditional | 04/13/1984SE |
| K823077 | Urinary Bladder Temp. Sensor #81-003FLL · Traditional | 03/09/1983SE |
Questions and answers
When was Biosign cleared by the FDA?
Biosign (K872867) received a 510(k) decision of Substantially Equivalent on July 6, 1988, 351 days after the submission was received.
What is the product code of K872867?
The FDA product code is FRC – Indicator, Biological Sterilization Process, a Class II (moderate risk) device regulated under 21 CFR 880.2800.