STEAM DOT BLU PROCESS INDICATOR— 510(k) K111453

Name: FDA 510(k) clearance K111453
Creator: U.S. Food and Drug Administration
Published: 2012-04-05

Substantially Equivalent

Propper Mfg. Co., Inc.

FDA 510(k) clearance K111453 for STEAM DOT BLU PROCESS INDICATOR, Substantially Equivalent on 2012-04-05. Applicant: Propper Mfg. Co., Inc.. Device class: 2.

Clearance details

Applicant: Propper Mfg. Co., Inc.
Product code: Product code JOJ
Device class: Class 2
Regulation: 21 CFR 880.2800
Advisory panel: General Hospital
Date received: 2011-05-25
Decision date: 2012-04-05
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Long Island, NY, 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 Propper Mfg. Co., Inc.

view all

K102894 — CLASSIX CHEMICAL STERILIZATION INDICATOR2011-05-25
K082620 — ONCE-A-DAY VERTOS TEST PACK2009-07-08
K031152 — PROPPER VAPOR LINE PCD (STEAM STERILIZATION PROCESS CHALLENGE TEST)2004-08-17
K991618 — BI-O.K. SELF-CONTAINED BIOLOGICAL INDICATOR2001-01-24
K991276 — PASS/FAIL CHALLENGE PACK1999-07-12

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