Cleared Traditional

K260354 - Foster Plus-22L (SNK/CE-F22)

K260354 is an FDA 510(k) clearance for Foster Plus-22L (SNK/CE-F22), manufactured by Zhejiang Fomos Medical Technology Co., Ltd.. The device is a Class 2 General Hospital device with product code FLE cleared through the Traditional 510(k) pathway after a 269-day FDA review.

K260354 · Zhejiang Fomos Medical Technology Co., Ltd. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2026
Decision
269d
Days
Class 2
Risk

K260354 is an FDA 510(k) clearance for the Foster Plus-22L (SNK/CE-F22). Classified as Sterilizer, Steam (product code FLE), Class II - Special Controls.

Submitted by Zhejiang Fomos Medical Technology Co., Ltd. (Zhejiang, CN). The FDA issued a Cleared decision on October 30, 2026 after a review of 269 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6880 - 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.

FDA 510(k) Submission Details - K260354

510(k) Number K260354 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 2026
Decision Date October 30, 2026
Days to Decision 269 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
140d slower than avg
Panel avg: 129d · This submission: 269d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FLE Device Classification - Class 2, Special Controls

Product Code FLE Sterilizer, Steam
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6880
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

Sterling Medical Devices, LLC dba Vantage MedTech
Indre Larson

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 - FLE Sterilizer, Steam

All 185
Devices cleared under the same product code (FLE) and FDA review panel - the closest regulatory comparables to K260354.
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K260354 · Foster Plus-22L (SNK/CE-F22)
Download PDF FDA Summary Zhejiang Fomos Medica…