Cleared Traditional

K897045 - BOWIE-DICK TEST CARD CATALOG NUMBER 008018

K897045 is an FDA 510(k) clearance for BOWIE-DICK TEST CARD CATALOG NUMBER 008018, manufactured by Edward Weck, Inc.. The device is a Class 2 General Hospital device with product code JOJ cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K897045 · Edward Weck, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1990
Decision
58d
Days
Class 2
Risk

K897045 is an FDA 510(k) clearance for the BOWIE-DICK TEST CARD CATALOG NUMBER 008018. Classified as Indicator, Physical/chemical Sterilization Process (product code JOJ), Class II - Special Controls.

Submitted by Edward Weck, Inc. (Research Triangle Pa, US). The FDA issued a Cleared decision on February 15, 1990 after a review of 58 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 Edward Weck, Inc. devices

FDA 510(k) Submission Details - K897045

510(k) Number K897045 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 1989
Decision Date February 15, 1990
Days to Decision 58 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
71d faster than avg
Panel avg: 129d · This submission: 58d
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 142
Devices cleared under the same product code (JOJ) and FDA review panel - the closest regulatory comparables to K897045.
STERRAD CHEMICAL INDICATOR
K921910 · Johnson & Johnson Medical, Inc. · Oct 1993
CHEMDI-VHP CHEMICAL INDICATOR
K922485 · American Sterilizer Co. · Sep 1993
SERIM PERACETIC ACID REAGENT STRIPS
K910320 · Serim Research Corp. · May 1991
TOWER SELF SEAL STERILIZATION POUCH
K895422 · Baxter Healthcare Corp · Nov 1989
SEALING TAPE, STERILIZATION INDICATOR
K890755 · Spsmedical Supply Corp. · Aug 1989
C-VAPOR STERILIZATION INDICATOR, CHEMICAL VAPOR
K890757 · Spsmedical Supply Corp. · Aug 1989