Cleared Traditional

K810311 - STERI-VERS

K810311 is an FDA 510(k) clearance for STERI-VERS, manufactured by The Hilrad Co.. The device is a Class 2 General Hospital device with product code LDS cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K810311 · The Hilrad Co. · General Hospital
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Apr 1981
Decision
71d
Days
Class 2
Risk

K810311 is an FDA 510(k) clearance for the STERI-VERS. Classified as Device, Pasteurization, Hot Water (product code LDS), Class II - Special Controls.

Submitted by The Hilrad Co. (Mchenry, US). The FDA issued a Cleared decision on April 17, 1981 after a review of 71 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6991 - 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 The Hilrad Co. devices

FDA 510(k) Submission Details - K810311

510(k) Number K810311 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 05, 1981
Decision Date April 17, 1981
Days to Decision 71 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
58d faster than avg
Panel avg: 129d · This submission: 71d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LDS Device Classification - Class 2, Special Controls

Product Code LDS Device, Pasteurization, Hot Water
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6991
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.