Cleared Traditional

K031152 - PROPPER VAPOR LINE PCD (STEAM STERILIZATION PROCESS CHALLENGE TEST)

K031152 is an FDA 510(k) clearance for PROPPER VAPOR LINE PCD (STEAM STERILIZA..., manufactured by Propper Mfg. Co., Inc.. The device is a Class 2 General Hospital device with product code JOJ cleared through the Traditional 510(k) pathway after a 494-day FDA review.

K031152 · Propper Mfg. Co., Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2004
Decision
494d
Days
Class 2
Risk

K031152 is an FDA 510(k) clearance for the PROPPER VAPOR LINE PCD (STEAM STERILIZATION PROCESS CHALLENGE TEST). Classified as Indicator, Physical/chemical Sterilization Process (product code JOJ), Class II - Special Controls.

Submitted by Propper Mfg. Co., Inc. (Long Island, US). The FDA issued a Cleared decision on August 17, 2004 after a review of 494 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.2800 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Propper Mfg. Co., Inc. devices

FDA 510(k) Submission Details - K031152

510(k) Number K031152 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 2003
Decision Date August 17, 2004
Days to Decision 494 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
365d slower than avg
Panel avg: 129d · This submission: 494d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JOJ Device Classification - Class 2, Special Controls

Product Code JOJ Indicator, Physical/chemical Sterilization Process
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.2800
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - JOJ Indicator, Physical/chemical Sterilization Process

All 246
Devices cleared under the same product code (JOJ) and FDA review panel - the closest regulatory comparables to K031152.
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STERITEC EMU-GRAPH, MODEL NO. CI 131/US
K040901 · Steritec Products, Inc. · Sep 2004
SPSMEDICAL AIRVIEW BOWIE DICK TEST PACK
K041017 · Spsmedical Supply Corp. · Jun 2004
MODIFICATION TO STERRAD SEALSURE CHEMICAL INDICATOR TAPE
K040742 · Advanced Sterilization Products · Apr 2004
MODIFIED BROWNE PACKAGING AND LABEL STEAM PROCESS INDICATOR
K032801 · Albert Browne , Ltd. · Oct 2003