CELERITY 20 HP Challenge Pack— 510(k) K220473

Substantially Equivalent

Steris

FDA 510(k) clearance K220473 for CELERITY 20 HP Challenge Pack, Substantially Equivalent on 2022-03-18. Applicant: Steris. Device class: 2.

Clearance details

Applicant: Steris
Product code: Code FRC
Device class: Class 2
Regulation: 21 CFR 880.2800
Advisory panel: General Hospital
Date received: 2022-02-18
Decision date: 2022-03-18
Decision: Substantially Equivalent
Clearance type: Special
Location: Mentor, OH, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FRC

K260766 — Celerity 5 HP Biological Indicator (LCB052)2026-04-08
K252680 — Celerity 20 HP Biological Indicator2025-09-24
K251122 — Terragene® Bionova® BT20 Biological Indicator2025-08-04
K251452 — Celerity 5 HP Biological Indicator (LCB052) +3 more2025-06-06
K250044 — Celerity 5 HP Biological Indicator (LCB052) +3 more2025-02-06

More clearances from Steris

DEN240075 — Prolystica Pass Thru Disinfectant Wipes2026-05-01
K242773 — Electro Lube NXT2025-04-15
DEN230085 — VERIFY RESI-TEST SLIDE-THRU Cleaning Process Protein (CPP) Indicator2024-11-12
K242189 — CELERITY HP Indicator Tape (PCC077)2024-08-20
K241344 — MetriCide OPA Plus Solution Test Strip2024-06-11

Data sourced from openFDA. This site is unofficial and independent of the FDA.