Cleared Traditional

K150243 - Invictus Medical GelShield

K150243 is an FDA 510(k) clearance for Invictus Medical GelShield, manufactured by Invictus Medical, Inc.. The device is a Class 1 General Hospital device with product code FMP cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K150243 · Invictus Medical, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2015
Decision
88d
Days
Class 1
Risk

K150243 is an FDA 510(k) clearance for the Invictus Medical GelShield. Classified as Protector, Skin Pressure (product code FMP), Class I - General Controls.

Submitted by Invictus Medical, Inc. (San Antonio, US). The FDA issued a Cleared decision on May 1, 2015 after a review of 88 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6450 - 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: 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 Invictus Medical, Inc. devices

FDA 510(k) Submission Details - K150243

510(k) Number K150243 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 2015
Decision Date May 01, 2015
Days to Decision 88 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
41d faster than avg
Panel avg: 129d · This submission: 88d
Pathway characteristics
Predicate-based equivalence.

FMP Device Classification - Class 1, General Controls

Product Code FMP Protector, Skin Pressure
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6450
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Consultant

Navigant Consulting
Scott Thiel

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
NCT02224859 Withdrawn Interventional Industry-sponsored

Invictus Medical, Medical Cranial Support Device (CSD) is a Device Safety Study in Infants at Risk of Head Ulcers.

Clinical Safety and Utility of the Invictus Cranial Support Device (CSD)

1
Site
Open label
Masking
Condition studied Other Preterm Infants
Study design Single group
Eligibility All sexes · 30 Weeks+ · Healthy volunteers accepted
Principal investigator Mustafa . Suterwala, MD
Sponsor Invictus Medical, Inc. (industry)
Started 2014-03-01 → Primary completion 2015-01-01
Primary outcome
HCP assessments of the products form, fit, likely effectiveness, and safety for internal decision making and for support of an FDA 510K submission to demonstrate form and fit as it relates to a predicate device.
View full study on ClinicalTrials.gov

Regulatory Peers - FMP Protector, Skin Pressure

All 8
Devices cleared under the same product code (FMP) and FDA review panel - the closest regulatory comparables to K150243.
MEDSURG STERILE IMAGING PRODUCTS
K934731 · Medsurg Industries, Inc. · Mar 1994
DECUBICARE PADS & ACCESSORIES
K820584 · Abco Dealers, Inc. · Mar 1982
HEEL OR ELBOW PROTECTOR
K812344 · Fred Sammons, Inc. · Sep 1981
SCANLAN VASCU-STATT
K802829 · Scanlan Intl., Inc. · Jan 1981
SPAN AIDS KIT
K792297 · American Hospital Supply Corp. · Dec 1979
HEEL OR ELBOW PROTECTOR
K772419 · Fred Sammons, Inc. · Jan 1978