Cleared Traditional

K842405 - DR. GOULD HAND PACK SUSTOM STERIL

K842405 is the FDA 510(k) clearance for DR. GOULD HAND PACK SUSTOM STERIL by Pro-Lab, Inc.. It is a Class 2 General Hospital device (product code FRG) cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K842405 · Pro-Lab, Inc. · General Hospital
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Aug 1984
Decision
57d
Days
Class 2
Risk

K842405 is an FDA 510(k) clearance for the DR. GOULD HAND PACK SUSTOM STERIL. Classified as Wrap, Sterilization (product code FRG), Class II - Special Controls.

Submitted by Pro-Lab, Inc. (Walker, US). The FDA issued a Cleared decision on August 15, 1984 after a review of 57 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 Pro-Lab, Inc. devices

Submission Details

510(k) Number K842405 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 1984
Decision Date August 15, 1984
Days to Decision 57 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 129d · This submission: 57d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 119
Devices cleared under the same product code (FRG) and FDA review panel - the closest regulatory comparables to K842405.
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K842644 · Deroyal Industries, Inc. · Nov 1984
STERILE O.R. BASIN KIT PRODUCT LINE
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K841156 · American Sterilizer Co. · Apr 1984
JAKOBI SURG. INSTRUMENTS #2 70/71
K834193 · Imm Enterprises , Ltd. · Feb 1984