Cleared Traditional

K241036 - Autoclave Indicator Tape (FDA 510(k) Clearance)

Also includes:
EO Indicator Tape

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

K241036 · Jiangmen New Era External Use Drug Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2024
Decision
245d
Days
Class 2
Risk

K241036 is an FDA 510(k) clearance for the Autoclave Indicator Tape. Classified as Indicator, Physical/chemical Sterilization Process (product code JOJ), Class II - Special Controls.

Submitted by Jiangmen New Era External Use Drug Co., Ltd. (Jiangmen, CN). The FDA issued a Cleared decision on December 17, 2024 after a review of 245 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 Jiangmen New Era External Use Drug Co., Ltd. devices

Submission Details

510(k) Number K241036 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 2024
Decision Date December 17, 2024
Days to Decision 245 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
117d slower than avg
Panel avg: 128d · This submission: 245d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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

Shanghai SUNGO Management Consulting Co., Ltd.
Ivy Wang

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 264
Devices cleared under the same product code (JOJ) and FDA review panel - the closest regulatory comparables to K241036.
LF Process Indicator Tape for Steam Sterilization
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SafeSecure Steam Sterilization Process Indicator (4012, 4013, 4014, 4016)
K251991 · Shenzhen Safesecure Medical Infection Control Tech Co. , Ltd. · Dec 2025
DISINTEK™ PA Test Strips
K251035 · Serim Research · Jun 2025
Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118
K251048 · STERIS Corporation · May 2025
VERIFY STEAM Integrating Indicator
K243876 · STERIS Corporation · Apr 2025
Green Card Bowie-Dick Test (BD115)
K250172 · Steritec Products, Inc. (A Getinge Company) · Feb 2025