Cleared Traditional

Pen Injector (K240774) - FDA 510(k) Clearance

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

K240774 · Wuxi Nest Biotechnology Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2024
Decision
89d
Days
Class 2
Risk

K240774 is an FDA 510(k) clearance for the Pen Injector. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Wuxi Nest Biotechnology Co., Ltd. (Wuxi, CN). The FDA issued a Cleared decision on June 18, 2024 after a review of 89 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5860 - 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 Wuxi Nest Biotechnology Co., Ltd. devices

Submission Details

510(k) Number K240774 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 2024
Decision Date June 18, 2024
Days to Decision 89 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
40d faster than avg
Panel avg: 129d · This submission: 89d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FMF Syringe, Piston
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5860
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

Icas Group
Ryan Li

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 - FMF Syringe, Piston

All 239
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K240774.
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