Cleared Traditional

K191166 - DigniCap Delta

K191166 is an FDA 510(k) clearance for DigniCap Delta, manufactured by Dignitana, Inc.. The device is a Class 2 General & Plastic Surgery device with product code PMC cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K191166 · Dignitana, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2019
Decision
56d
Days
Class 2
Risk

K191166 is an FDA 510(k) clearance for the DigniCap Delta. Classified as Scalp Cooling System (product code PMC), Class II - Special Controls.

Submitted by Dignitana, Inc. (Dallas, US). The FDA issued a Cleared decision on June 26, 2019 after a review of 56 days - a notably fast clearance cycle.

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: 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 Dignitana, Inc. devices

FDA 510(k) Submission Details - K191166

510(k) Number K191166 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 2019
Decision Date June 26, 2019
Days to Decision 56 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
59d faster than avg
Panel avg: 115d · This submission: 56d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Consultant

Experien Group
Valerie Defiesta-Ng

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 - PMC Scalp Cooling System

Devices cleared under the same product code (PMC) and FDA review panel - the closest regulatory comparables to K191166.
Eva Scalp Cooling System
K252289 · Stemtech Medical Devices Private Limited · Nov 2025
Portable Scalp Cooling System
K211526 · Cooler Heads Care, Inc. · Oct 2021
Paxman Scalp Cooler
K173032 · Paxman Coolers Limited · Jun 2018
DigniCap Scalp Cooling System
K170871 · Dignitana AB · Jul 2017
Paxman Scalp Cooler
K163484 · Paxman Coolers Limited · Apr 2017
Dignitana AB DigniCap System
DEN150010 · Dignitana AB · Dec 2015