Cleared Traditional

K871672 - STERILIZATION INDICATOR FOR FLASH STERI...

K871672 is an FDA 510(k) clearance for STERILIZATION INDICATOR FOR FLASH STERI..., manufactured by Propper Mfg. Co., Inc.. The device is a Class 2 General Hospital device with product code LRT cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K871672 · Propper Mfg. Co., Inc. · General Hospital
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Jun 1987
Decision
34d
Days
Class 2
Risk

K871672 is an FDA 510(k) clearance for the STERILIZATION INDICATOR FOR FLASH STERILIZATION. Classified as Indicator, Sterilization (product code LRT), Class II - Special Controls.

Submitted by Propper Mfg. Co., Inc. (Long Island City, US). The FDA issued a Cleared decision on June 1, 1987 after a review of 34 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.2800 - 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 Propper Mfg. Co., Inc. devices

FDA 510(k) Submission Details - K871672

510(k) Number K871672 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 1987
Decision Date June 01, 1987
Days to Decision 34 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 129d · This submission: 34d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LRT Device Classification - Class 2, Special Controls

Product Code LRT Indicator, Sterilization
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.2800
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.