Cleared Traditional

K844512 - DART DAILY AIR REMOVAL TEST

K844512 is an FDA 510(k) clearance for DART DAILY AIR REMOVAL TEST, manufactured by American Sterilizer Co.. The device is a Class 2 General Hospital device with product code JOJ cleared through the Traditional 510(k) pathway after a 121-day FDA review.

K844512 · American Sterilizer Co. · General Hospital
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Mar 1985
Decision
121d
Days
Class 2
Risk

K844512 is an FDA 510(k) clearance for the DART DAILY AIR REMOVAL TEST. Classified as Indicator, Physical/chemical Sterilization Process (product code JOJ), Class II - Special Controls.

Submitted by American Sterilizer Co. (Erie, US). The FDA issued a Cleared decision on March 21, 1985 after a review of 121 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all American Sterilizer Co. devices

FDA 510(k) Submission Details - K844512

510(k) Number K844512 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 1984
Decision Date March 21, 1985
Days to Decision 121 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
8d faster than avg
Panel avg: 129d · This submission: 121d
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 153
Devices cleared under the same product code (JOJ) and FDA review panel - the closest regulatory comparables to K844512.
LABEL, STERILIZATION INDICATOR
K890764 · Spsmedical Supply Corp. · Aug 1989
STRIP, STERILIZATION INDICATOR
K890765 · Spsmedical Supply Corp. · Aug 1989
BIO-CHALLENGE TEST PAK
K851804 · Propper Mfg. Co., Inc. · Jul 1985
STERILIZATION PROCESS INDICATOR
K841168 · Parke-Davis Co. · May 1984
OK FLASH STERILIZATION INDICATOR
K834353 · Propper Mfg. Co., Inc. · Mar 1984
CHEMDI STEAM & GAS STERILIZATION INDICA
K823074 · American Sterilizer Co. · Nov 1982