Cleared Traditional

K163484 - Paxman Scalp Cooler

K163484 is an FDA 510(k) clearance for Paxman Scalp Cooler, manufactured by Paxman Coolers Limited. The device is a Class 2 General & Plastic Surgery device with product code PMC cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K163484 · Paxman Coolers Limited · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Apr 2017
Decision
126d
Days
Class 2
Risk

K163484 is an FDA 510(k) clearance for the Paxman Scalp Cooler. Classified as Scalp Cooling System (product code PMC), Class II - Special Controls.

Submitted by Paxman Coolers Limited (Huddersfield, GB). The FDA issued a Cleared decision on April 17, 2017 after a review of 126 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4360 - 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 Paxman Coolers Limited devices

FDA 510(k) Submission Details - K163484

510(k) Number K163484 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 2016
Decision Date April 17, 2017
Days to Decision 126 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
11d slower than avg
Panel avg: 115d · This submission: 126d
Pathway characteristics
Predicate-based equivalence.

PMC Device Classification - Class 2, Special Controls

Product Code PMC Scalp Cooling System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4360
Definition A Scalp Cooling System Is Intended To Reduce Or Prevent The Frequency And Severity Of Alopecia During Chemotherapy In Which Alopecia-inducing Chemotherapeutic Agents Are Used.
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

Emergo Global Consulting, LLC
Richard A. VINCINS

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
NCT01986140 Unknown Interventional

Scalp Cooling to Prevent Chemo-induced Hair Loss

Scalp Cooling for Alopecia Prevention (SCALP)

236
Patients (actual)
7
Sites
Treatment
Purpose
Single blind
Masking
Condition studied Breast Cancer; Alopecia
Study design Parallel
Eligibility Female only · 18 Years+
Principal investigator Julie Nangia, M.D.
Sponsor Julie Nangia
Started 2014-05-15 → Primary completion 2017-02-10 → Completed 2022-12-01
Primary outcome
Hair Preservation
Secondary outcome
Time to First Recurrence and Overall Survival
View full study on ClinicalTrials.gov