Cleared Traditional

K041017 - SPSMEDICAL AIRVIEW BOWIE DICK TEST PACK

K041017 is an FDA 510(k) clearance for SPSMEDICAL AIRVIEW BOWIE DICK TEST PACK, manufactured by Spsmedical Supply Corp.. The device is a Class 2 General Hospital device with product code JOJ cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K041017 · Spsmedical Supply Corp. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2004
Decision
66d
Days
Class 2
Risk

K041017 is an FDA 510(k) clearance for the SPSMEDICAL AIRVIEW BOWIE DICK TEST PACK. Classified as Indicator, Physical/chemical Sterilization Process (product code JOJ), Class II - Special Controls.

Submitted by Spsmedical Supply Corp. (Rush, US). The FDA issued a Cleared decision on June 25, 2004 after a review of 66 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Spsmedical Supply Corp. devices

FDA 510(k) Submission Details - K041017

510(k) Number K041017 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 2004
Decision Date June 25, 2004
Days to Decision 66 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 129d · This submission: 66d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Entela, Inc.
NEIL E DEVINE

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - JOJ Indicator, Physical/chemical Sterilization Process

All 217
Devices cleared under the same product code (JOJ) and FDA review panel - the closest regulatory comparables to K041017.
SERIM PERACETIC ACID CHEMICAL INDICATOR
K052388 · Serim Research Corp. · Dec 2005
THE RELIANCE PI PROCESS INDICATOR, MODEL D5116
K043482 · STERIS Corporation · Dec 2004
PROPPER VAPOR LINE PCD (STEAM STERILIZATION PROCESS CHALLENGE TEST)
K031152 · Propper Mfg. Co., Inc. · Aug 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
SPSMEDICAL GAS PLASMA CHEMICAL INDICATOR
K030680 · Spsmedical Supply Corp. · May 2003

FDA 510(k) Resources - General Hospital

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.