Cleared Traditional

Vented Vial Adapter 20mm (K213513) - FDA 510(k) Clearance

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

K213513 · West Pharma Services Il, Ltd. · General Hospital
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Aug 2022
Decision
302d
Days
Class 2
Risk

K213513 is an FDA 510(k) clearance for the Vented Vial Adapter 20mm. Classified as Set, I.v. Fluid Transfer (product code LHI), Class II - Special Controls.

Submitted by West Pharma Services Il, Ltd. (Ra'Anana Central, IL). The FDA issued a Cleared decision on August 31, 2022 after a review of 302 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5440 - 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. Elevated predicate reliance profile. 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 West Pharma Services Il, Ltd. devices

Submission Details

510(k) Number K213513 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 2021
Decision Date August 31, 2022
Days to Decision 302 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
173d slower than avg
Panel avg: 129d · This submission: 302d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LHI Set, I.v. Fluid Transfer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5440
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

West Pharmaceutical Services, Inc.
Fred Cowdery

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 - LHI Set, I.v. Fluid Transfer

All 64
Devices cleared under the same product code (LHI) and FDA review panel - the closest regulatory comparables to K213513.
MixJect® Transfer Device
K230464 · West Pharma Services Il, Ltd. · May 2023
Vial Adapter
K222718 · Hangzhou Qiantang Longyue Biotechnology Co., Ltd. · Mar 2023
Vented Vial Transfer Pin
K221406 · Jiangsu Caina Medical Co.,Ltd · Oct 2022
Advcare Vial Direct to Bag (VDB) Needle-free Admixture Devices
K212525 · Advcare Medical · Aug 2022
Vial Adapter Ø13mm
K220856 · Avenir Performance Europ?enne Medical (Apem) · Jun 2022
freeflex+ Transfer Adapter
K212445 · Fresenius Kabi AG · Jun 2022