Cleared Traditional

K233762 - SteroScope® Sterilization Technology System (FDA 510(k) Clearance)

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K233762 · Ideate Medical, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2024
Decision
216d
Days
Class 2
Risk

K233762 is an FDA 510(k) clearance for the SteroScope® Sterilization Technology System. Classified as Sterilizer, Chemical (product code MLR), Class II - Special Controls.

Submitted by Ideate Medical, Inc. (St. Louis, US). The FDA issued a Cleared decision on June 27, 2024 after a review of 216 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6860 - 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 Ideate Medical, Inc. devices

Submission Details

510(k) Number K233762 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 24, 2023
Decision Date June 27, 2024
Days to Decision 216 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
88d slower than avg
Panel avg: 128d · This submission: 216d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MLR Sterilizer, Chemical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6860
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

Corrigan Regulatory Consulting
Kevin Corrigan

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 - MLR Sterilizer, Chemical

All 46
Devices cleared under the same product code (MLR) and FDA review panel - the closest regulatory comparables to K233762.
STERRAD 100NX Sterilization System with ALLClear Technology (10104)
K252843 · Advanced Sterilization Products, Inc. · Apr 2026
STERRAD® 100NX Sterilizer with ALLClear™ Technology (10104)
K250802 · Advanced Sterilization Products, Inc. · Apr 2025
LOWTEM Crystal 120
K231893 · Lowtem Co., Ltd. · Sep 2024
STERRAD® 100NX Sterilizer with ALLClear™ Technology and ULTRA GI™ Cycle (10104)
K234082 · Advanced Sterilization Products · Jul 2024
V-PRO maX 2 Low Temperature Sterilization System
K233065 · Steris · Oct 2023
V-PRO maX 2 Low Temperature Sterilization System
K223476 · STERIS Corporation · Aug 2023