Cleared Traditional

K250718 - swiftPro System (SWF-SPS) (FDA 510(k) Clearance)

Also includes:
Swift System (SWF-SYS)

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence.

K250718 · Emblation Limited · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2025
Decision
151d
Days
Class 2
Risk

K250718 is an FDA 510(k) clearance for the swiftPro System (SWF-SPS). Classified as System, Ablation, Microwave And Accessories (product code NEY), Class II - Special Controls.

Submitted by Emblation Limited (Stirling, GB). The FDA issued a Cleared decision on August 8, 2025 after a review of 151 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4400 - the FDA general and plastic surgery 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 & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Emblation Limited devices

Submission Details

510(k) Number K250718 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 2025
Decision Date August 08, 2025
Days to Decision 151 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
37d slower than avg
Panel avg: 114d · This submission: 151d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code NEY System, Ablation, Microwave And Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4400
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Consultant

Blackwell Device Consulting
Angela Blackwell

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.

Clinical Evidence

ClinicalTrials.gov
NCT05371834 Active not recruiting Interventional Industry-sponsored

Microwave Treatment of Common and Plantar Warts

Pivotal Study to Assess the Clinical Efficacy and Safety of Microwave Treatment in Warts

119
Patients (actual)
6
Sites
Treatment
Purpose
Open label
Masking
Condition studied Warts
Study design Parallel
Eligibility All sexes · 18 Years+
Principal investigator Dr Bhatia
Sponsor Blackwell Device Consulting (industry)
Started 2022-07-06 → Primary completion 2024-08-01 → Completed 2025-03-01
Primary outcome
Clearance of all treated warts, each of which is defined as "resolved" or "not resolved" based on the classification by the blinded site investigator assessing the treated warts at three months post final treatment (up to 5 warts in total).
Secondary outcome
Clearance of all treated warts at three months post final treatment, each of which is defined as "lesion no longer visible" but assessed by the majority of three independent blinded assessors using photographs
View full study on ClinicalTrials.gov

Regulatory Peers - NEY System, Ablation, Microwave And Accessories

All 67
Devices cleared under the same product code (NEY) and FDA review panel - the closest regulatory comparables to K250718.
Microwave Ablation Device
K252632 · Nanjing Dewen Medical Technology Co., Ltd. · Mar 2026
Disposable Microwave Ablation Antenna (DW-XR-II1, DW-XR-II3, DW-XR-II4, DW-XR-II14, DW-XR-II5, DW-XR-II6, DW-XR-II7, DW-XR-II8, DW-XR-II9, DW-XR-II10, DW-XR-II18, DW-XR-II19, DW-XR-II20, DW-XR-II21, DW-DG-II6, DW-DG-II7, DW-DG-II9, DW-DG-II10, DW-DG-II13)
K253771 · Nanjing Devin Medical Technology Co., Ltd. · Mar 2026
Microwave Ablation Generator (KY-2000A, KY-2100A)
K241827 · Canyon Medical, Inc. · Sep 2024
Microwave Ablation Antennas
K241825 · Canyon Medical, Inc. · Sep 2024
IntelliBlate Microwave Ablation System Console (IB-CON)
K240480 · Varian Medical Systems, Inc. · Jul 2024
Temperature Sensor Probe (ABL-18TP20)
K240784 · Varian Medical Systems, Inc. · May 2024