SPORVIEW— 510(k) K905425
Substantially EquivalentSpsmedical Supply Corp.
FDA 510(k) clearance K905425 for SPORVIEW, Substantially Equivalent on 1992-03-27. Applicant: Spsmedical Supply Corp.. Device class: 2.
Clearance details
- Applicant
- Spsmedical Supply Corp.
- Product code
- Code FRC
- Device class
- Class 2
- Regulation
- 21 CFR 880.2800
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Rochester, NY, US
Recent devices under product code FRC
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- K110152 — SPSMEDICAL VAPORIZED HYDROGEN PEROXIDE CHEMICAL INDICATORS
- K102363 — SPSMEDICAL EMPLUS 270 F STEAM EMULATOR MODEL EMP-104, EMP-1004
Recalls naming K905425
K-number listed on FDA's recall record- Z-1141-2025 — Biological, Bio52 HealthFirst Mail In Monitoring System, 52 Tests, Item: 1003600. Biological, Bio12 HealthFirst Mail In Monitoring System, 12 Tests, Item: 1003580
- Z-1790-2022 — a. SporView Culture Set SporView Sterilization Biological Indicator Kit Steam / EO Gas / Dry Heat / Chemical Vapor Model Number: CS-020 b. SPORVIEW CULTURE SET SporView Sterilization Biological Indicator Kit Steam / EO Gas / Dry Heat / Chemical Vapor Model Number: CS-100
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K905425.
Data sourced from openFDA. This site is unofficial and independent of the FDA.