Cleared Traditional

K221556 - T-Line Hernia Mesh

K221556 is an FDA 510(k) clearance for T-Line Hernia Mesh, manufactured by Deep Blue Medical Advances, Inc.. The device is a Class 2 General & Plastic Surgery device with product code FTL cleared through the Traditional 510(k) pathway after a 181-day FDA review.

K221556 · Deep Blue Medical Advances, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2022
Decision
181d
Days
Class 2
Risk

K221556 is an FDA 510(k) clearance for the T-Line Hernia Mesh. Classified as Mesh, Surgical, Polymeric (product code FTL), Class II - Special Controls.

Submitted by Deep Blue Medical Advances, Inc. (Durham, US). The FDA issued a Cleared decision on November 28, 2022 after a review of 181 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.3300 - 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 Deep Blue Medical Advances, Inc. devices

FDA 510(k) Submission Details - K221556

510(k) Number K221556 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 2022
Decision Date November 28, 2022
Days to Decision 181 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
66d slower than avg
Panel avg: 115d · This submission: 181d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FTL Device Classification - Class 2, Special Controls

Product Code FTL Mesh, Surgical, Polymeric
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.3300
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

Lincé Consulting, LLC
Nancy Lincé

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 - FTL Mesh, Surgical, Polymeric

All 198
Devices cleared under the same product code (FTL) and FDA review panel - the closest regulatory comparables to K221556.
Pitch PaSoft Tissue Reinforcement Device
K230671 · Xiros, Ltd. · May 2023
T-Line Hernia Mesh
K230227 · Deep Blue Medical Advances, Inc. · Feb 2023
Parietene Macroporous Mesh
K223218 · Sofradim Production · Dec 2022
ProGrip Self-Gripping Polypropylene Mesh
K220540 · Covidien · Sep 2022
Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device
K220091 · Xiros, Ltd. · Aug 2022
Symbotex Composite Mesh, ProGrip Self-Gripping Polyester Mesh, Parietex Hydrophilic 2D 3D Anatomical Mesh, Versatex Monofilament Mesh
K220586 · Sofradim Production · Jun 2022