Cleared Traditional

K770078 - CASTLE TEC-TEST STEAM STERI. INTEGRATOR

K770078 is an FDA 510(k) clearance for CASTLE TEC-TEST STEAM STERI. INTEGRATOR, manufactured by Castle Co.. The device is a Class 2 General Hospital device with product code JOJ cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K770078 · Castle Co. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1977
Decision
46d
Days
Class 2
Risk

K770078 is an FDA 510(k) clearance for the CASTLE TEC-TEST STEAM STERI. INTEGRATOR. Classified as Indicator, Physical/chemical Sterilization Process (product code JOJ), Class II - Special Controls.

Submitted by Castle Co. (Mchenry, US). The FDA issued a Cleared decision on February 28, 1977 after a review of 46 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 Castle Co. devices

FDA 510(k) Submission Details - K770078

510(k) Number K770078 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 13, 1977
Decision Date February 28, 1977
Days to Decision 46 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
83d faster than avg
Panel avg: 129d · This submission: 46d
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.