Cleared Traditional

K220981 - SUPERPLAST Double-Occluder, SUPERPLAST Vascular Probe (FDA 510(k) Clearance)

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

K220981 · Fehling Surgical Instruments, Inc. · Cardiovascular device
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Apr 2023
Decision
381d
Days
Class 2
Risk

K220981 is an FDA 510(k) clearance for the SUPERPLAST Double-Occluder, SUPERPLAST Vascular Probe. Classified as Dilator, Vessel, Surgical (product code DWP), Class II - Special Controls.

Submitted by Fehling Surgical Instruments, Inc. (Kennesaw, US). The FDA issued a Cleared decision on April 20, 2023 after a review of 381 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4475 - the FDA cardiovascular device oversight 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 Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Fehling Surgical Instruments, Inc. devices

Submission Details

510(k) Number K220981 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 2022
Decision Date April 20, 2023
Days to Decision 381 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
256d slower than avg
Panel avg: 125d · This submission: 381d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DWP Dilator, Vessel, Surgical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4475
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 Cardiovascular devices follow this clearance model.

Regulatory Consultant

Jalex Medical
Jennifer Palinchik

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.