Cleared Traditional

K801109 - PROOF (BIOLOGICAL/CHEMICAL INDICATOR)

K801109 is an FDA 510(k) clearance for PROOF (BIOLOGICAL/CHEMICAL INDICATOR), manufactured by Amsco Co.. The device is a Class 2 General Hospital device with product code JOJ cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K801109 · Amsco Co. · General Hospital
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May 1980
Decision
18d
Days
Class 2
Risk

K801109 is an FDA 510(k) clearance for the PROOF (BIOLOGICAL/CHEMICAL INDICATOR). Classified as Indicator, Physical/chemical Sterilization Process (product code JOJ), Class II - Special Controls.

Submitted by Amsco Co. (Mchenry, US). The FDA issued a Cleared decision on May 30, 1980 after a review of 18 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 Amsco Co. devices

FDA 510(k) Submission Details - K801109

510(k) Number K801109 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 1980
Decision Date May 30, 1980
Days to Decision 18 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
111d faster than avg
Panel avg: 129d · This submission: 18d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JOJ Device Classification - Class 2, Special Controls

Product Code JOJ Indicator, Physical/chemical Sterilization Process
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.

Regulatory Peers - JOJ Indicator, Physical/chemical Sterilization Process

All 220
Devices cleared under the same product code (JOJ) and FDA review panel - the closest regulatory comparables to K801109.
STERIGAGE EO ETHYL. OXIDE STERIL. INDIC.
K802634 · Organon, Inc. · Dec 1980
CHEMDI
K801428 · American Sterilizer Co. · Aug 1980
3M STEAM STERILIZATION INDICATOR
K801057 · 3M Company · Jun 1980
STERILIZATION PROCESS/ MAYO PAD
K792624 · Procter & Gamble Mfg. Co. · Jan 1980
BIOLOGICAL/CHEMICAL INDICATOR
K772135 · Amsco Co. · Dec 1977
CASTLE TEC-TEST STEAM STERI. INTEGRATOR
K770078 · Castle Co. · Feb 1977