STEAM STERILIZATION INTERGRATOR— 510(k) K012195

Name: FDA 510(k) clearance K012195
Creator: U.S. Food and Drug Administration
Published: 2002-05-07

Substantially Equivalent

Dana Products, Inc.

FDA 510(k) clearance K012195 for STEAM STERILIZATION INTERGRATOR, Substantially Equivalent on 2002-05-07. Applicant: Dana Products, Inc.. Device class: 2.

Clearance details

Applicant: Dana Products, Inc.
Product code: Product code JOJ
Device class: Class 2
Regulation: 21 CFR 880.2800
Advisory panel: General Hospital
Date received: 2001-07-13
Decision date: 2002-05-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: South Barrington, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JOJ

view all

K263267 — Endox Test Strips2026-10-16
K261992 — 3M Attest Steam Chemical Integrator (1243A, 1243B, 1243RE, 1243RES)2026-09-25
K260181 — LF Process Indicator Tape for Steam Sterilization2026-02-20
K251991 — SafeSecure Steam Sterilization Process Indicator (4012, 4013, 4014, 4016) +1 more2025-12-23
K251035 — DISINTEK PA Test Strips2025-06-03

More clearances from Dana Products, Inc.

view all

K133267 — DANA REUSABLE TEST PACK2014-02-11
K130135 — DANA REUSABLE BI TEST PACK2013-11-25
K120592 — DANA REUSABLE BOWIE TEST PACK FOR DANA BOWIE DICK INDICATORS2013-02-27
K110253 — REUSABLE TEST PACK FOR DANA EMULATING INDICATORS2011-04-29
K103321 — DANA REUSABLE TESTPACK FOR STEAM STERILIZATION FOR 10 MINUTE EXTENDED CYCLES2011-02-16

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