Cleared Traditional

K102783 - HINSON & HALE MEDICAL TECHNOLOGIES INFUSED (R) POLYESTER WRAPPERS

K102783 is an FDA 510(k) clearance for HINSON & HALE MEDICAL TECHNOLOGIES INFU..., manufactured by Hinson and Hale Medical Technologies, Inc.. The device is a Class 2 General Hospital device with product code FRG cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K102783 · Hinson and Hale Medical Technologies, Inc. · General Hospital
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Dec 2010
Decision
86d
Days
Class 2
Risk

K102783 is an FDA 510(k) clearance for the HINSON & HALE MEDICAL TECHNOLOGIES INFUSED (R) POLYESTER WRAPPERS. Classified as Wrap, Sterilization (product code FRG), Class II - Special Controls.

Submitted by Hinson and Hale Medical Technologies, Inc. (Austin, US). The FDA issued a Cleared decision on December 22, 2010 after a review of 86 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6850 - 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 Hinson and Hale Medical Technologies, Inc. devices

FDA 510(k) Submission Details - K102783

510(k) Number K102783 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2010
Decision Date December 22, 2010
Days to Decision 86 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 129d · This submission: 86d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FRG Device Classification - Class 2, Special Controls

Product Code FRG Wrap, Sterilization
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6850
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 Peers - FRG Wrap, Sterilization

All 188
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