Cleared Traditional

K982188 - STERI-PAK BOWIE DICK TEST PACK

K982188 is an FDA 510(k) clearance for STERI-PAK BOWIE DICK TEST PACK, manufactured by Steritec Products 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 151-day FDA review.

K982188 · Steritec Products Mfg Co, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1998
Decision
151d
Days
Class 2
Risk

K982188 is an FDA 510(k) clearance for the STERI-PAK BOWIE DICK TEST PACK. Classified as Indicator, Physical/chemical Sterilization Process (product code JOJ), Class II - Special Controls.

Submitted by Steritec Products Mfg Co, Inc. (Castle Rock, US). The FDA issued a Cleared decision on November 20, 1998 after a review of 151 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Steritec Products Mfg Co, Inc. devices

FDA 510(k) Submission Details - K982188

510(k) Number K982188 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 1998
Decision Date November 20, 1998
Days to Decision 151 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
22d slower than avg
Panel avg: 129d · This submission: 151d
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 217
Devices cleared under the same product code (JOJ) and FDA review panel - the closest regulatory comparables to K982188.
BROWNE SPORICIDIN PHENOL INDICATOR FOR SPORICIDIN STERILIZING AND DISINFECTING SOLUTION
K984613 · Albert Browne , Ltd. · Feb 1999
BROWNE SPORICIDIN GLUTARALDEHYDE INDICATOR FOR SPORICIDIN STERILIZING AND DISINFECTING SOLUTION
K984616 · Albert Browne , Ltd. · Feb 1999
BROWNE GA INDICATOR FOR CIDEX PRODUCTS
K981054 · Albert Browne , Ltd. · Dec 1998
PROPPER EO LINE ETHYLENE OXIDE STERILIZATION INTEGRATOR
K973585 · Propper Mfg. Co., Inc. · Nov 1998
STERITEC CROSS-CHECKS EO GAS STERILIZATION INTEGRATOR
K982547 · Steritec Products Mfg Co, Inc. · Oct 1998
BROWNE TST SINGLE USE BOWIE-DICK TYPE TEST PACK
K971971 · Board of Directors, Albert Browne , Ltd. · Jul 1998