Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

STERRAD VELOCITY Biological Indicator/Process Challenge Device and Reader

K-Number: K192025 · 2020-01-23

ApplicantAdvanced Sterilization Products (Asp)
Decision Date2020-01-23
Product CodeFRC
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

STERRAD VELOCITY Biological Indicator/Process Challenge Device and Reader is a medical device manufactured by Advanced Sterilization Products (Asp). It received FDA 510(k) clearance on 2020-01-23 under approval number K192025. The device is classified under product code FRC. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STERRAD VELOCITY Biological Indicator/Process Challenge Device and Reader?

STERRAD VELOCITY Biological Indicator/Process Challenge Device and Reader is a medical device that received FDA 510(k) clearance on 2020-01-23. It is manufactured by Advanced Sterilization Products (Asp). The 510(k) number is K192025.

When was STERRAD VELOCITY Biological Indicator/Process Challenge Device and Reader approved by the FDA?

STERRAD VELOCITY Biological Indicator/Process Challenge Device and Reader received FDA 510(k) clearance on 2020-01-23, under approval number K192025.

What company makes STERRAD VELOCITY Biological Indicator/Process Challenge Device and Reader?

STERRAD VELOCITY Biological Indicator/Process Challenge Device and Reader is manufactured by Advanced Sterilization Products (Asp).

What is the FDA product code for STERRAD VELOCITY Biological Indicator/Process Challenge Device and Reader?

The FDA product code for STERRAD VELOCITY Biological Indicator/Process Challenge Device and Reader is FRC.

Related Clinical Trials

NCT07613658 3D-Printed Versus Band-and-Loop Versus Denovo Space Maintainers in Primary Dentition. NOT_YET_RECRUITING NCT04910841 Feasibility of Using the "CGM GUARDIAN 2" Interstitial Fluid Glucose Measurement System in Intensive Care Medicine RECRUITING NCT06648486 Robot-assisted Training COMPLETED NCT07585110 Effectiveness of a Novel Scoliosis Therapy Using a Standing Scoliosis Therapy Device With Biological Feedback Mechanism COMPLETED NCT06832163 Close Loop Smart Weaning for INO With PPHN RECRUITING NCT07560878 Synaptic Mechanisms of Continuous Theta Burst Stimulation in Depression RECRUITING

Related PubMed Literature

PMID: 42181028 Systematic biocompatibility assessment of 4-µm surface silicone implants. Biomaterials and biosystems (2026) PMID: 42105288 Evaluating regulatory oversight through major Expert review of medical devices (2026) PMID: 42043129 Iatrogenic Microplastic Exposure: A Possible and Underrecognized Healthcare-Associated Exposure Framework in Human Medicotoxicological Risk. Toxics (2026) PMID: 41970523 Large language models in healthcare quality management: a European perspective on process automation and compliance. Frontiers in digital health (2026)

Other Devices by Advanced Sterilization Products (Asp)

K152189EVOTECH ECR K170039STERRAD VELOCITY Biological Indictator and Reader K182404STERRAD VELOCITY Biological Indicator K181472AEROFLEX(TM) Automatic Endoscope Reprocessor with AUTOSURE(TM) MRC Monitor

Related Devices (Code: FRC)

K1605463M Attest Rapid Readout Biological Indicator3M Company K151482BCR-30-min BI™ and RBIP-ST30™ Readout AccessoryBcr Diagnostics, Inc. K172474Celerity 20 HP Biological IndicatorSTERIS Corporation K172432SporView Rapid Read Biological IndicatorCrosstex/Spsmedical, A Division of Cantel Medical K163646Terragene Bionova(R) SCBI (BT220, BT221, BT222, BT223), Terragene Bionova (R) PCD (PCD220-C, PCD220-2, PCD222-C, PCD222-2), and Terragene Bionova(R) IC10/20FR Reader IncubatorTerragene S.A. K170427Anprolene SteriTestAndersen Sterilizers, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑