Cleared Traditional

SterileRight sterilization pouch and roll (K212338) - FDA 510(k) Clearance

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

K212338 · Sterileright Packaging Mfg., Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2021
Decision
97d
Days
Class 2
Risk

K212338 is an FDA 510(k) clearance for the SterileRight sterilization pouch and roll. Classified as Wrap, Sterilization (product code FRG), Class II - Special Controls.

Submitted by Sterileright Packaging Mfg., Inc. (Keelung City, TW). The FDA issued a Cleared decision on November 1, 2021 after a review of 97 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6850 - 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 Sterileright Packaging Mfg., Inc. devices

Submission Details

510(k) Number K212338 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 2021
Decision Date November 01, 2021
Days to Decision 97 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
32d faster than avg
Panel avg: 129d · This submission: 97d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FRG Wrap, Sterilization
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6850
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

Sen MU Technology Co., Ltd.
Uta Shih

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 - FRG Wrap, Sterilization

All 89
Devices cleared under the same product code (FRG) and FDA review panel - the closest regulatory comparables to K212338.
CareGUARD Sterilization Wrap
K213907 · Care Essentials Pty, Ltd. · Mar 2022
Sterilization Wraps
K220133 · Weihai Hongyu Nonwoven Fabric Products Co., Ltd. · Mar 2022
Steiking Packaging for Medical Devices
K210810 · Wipak OY · Jan 2022
Tyvek(R) Roll with CI for STERLINKTM Sterilizer
K212198 · Plasmapp Co,., Ltd. · Oct 2021
Turbett Instrument Pod
K202593 · Turbett Surgical, Inc. · May 2021
SIGMA Sterilization Pouch and Roll
K202462 · Sigma Medical Supplies Corporation · Apr 2021