Cleared Traditional

K141438 - WHITNEY MEDICAL SOLUTIONS ESHIELD

K141438 is an FDA 510(k) clearance for WHITNEY MEDICAL SOLUTIONS ESHIELD, manufactured by Whitney Medical Solutions. The device is a Class 2 General Hospital device with product code KKX cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K141438 · Whitney Medical Solutions · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2014
Decision
76d
Days
Class 2
Risk

K141438 is an FDA 510(k) clearance for the WHITNEY MEDICAL SOLUTIONS ESHIELD. Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by Whitney Medical Solutions (Niles, US). The FDA issued a Cleared decision on August 14, 2014 after a review of 76 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4370 - 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.

FDA 510(k) Submission Details - K141438

510(k) Number K141438 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 30, 2014
Decision Date August 14, 2014
Days to Decision 76 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 129d · This submission: 76d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

KKX Device Classification - Class 2, Special Controls

Product Code KKX Drape, Surgical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4370
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 Hospital devices follow this clearance model.

Regulatory Consultant

Regulatory Technology Services, LLC
SAAGAR PATEL

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 - KKX Drape, Surgical

All 323
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FDA 510(k) Resources - General Hospital

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.