Cleared Traditional

K874644 - STEAM AUTOCLAVE CONTROL. & DATALOG. BY DATACON

K874644 is an FDA 510(k) clearance for STEAM AUTOCLAVE CONTROL. & DATALOG. BY ..., manufactured by Pharmetics, Inc.. The device is a Class 2 General Hospital device with product code FLE cleared through the Traditional 510(k) pathway after a 75-day FDA review.

K874644 · Pharmetics, Inc. · General Hospital
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Jan 1988
Decision
75d
Days
Class 2
Risk

K874644 is an FDA 510(k) clearance for the STEAM AUTOCLAVE CONTROL. & DATALOG. BY DATACON. Classified as Sterilizer, Steam (product code FLE), Class II - Special Controls.

Submitted by Pharmetics, Inc. (Hauppauge, US). The FDA issued a Cleared decision on January 27, 1988 after a review of 75 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6880 - 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 Pharmetics, Inc. devices

FDA 510(k) Submission Details - K874644

510(k) Number K874644 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 1987
Decision Date January 27, 1988
Days to Decision 75 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
54d faster than avg
Panel avg: 129d · This submission: 75d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FLE Device Classification - Class 2, Special Controls

Product Code FLE Sterilizer, Steam
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6880
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 - FLE Sterilizer, Steam

All 139
Devices cleared under the same product code (FLE) and FDA review panel - the closest regulatory comparables to K874644.
PRESSURE STEAM STERILIZERS
K895848 · Scientific Device Laboratory, Inc. · Dec 1989
MITEK STERILIZATION TRAY
K893886 · Mitek Surgical Products, Inc. · Aug 1989
REBUILDING STERILIZERS
K882713 · Mdt Corp., Inc. · Aug 1988
MODIFIED CASTLE POWERCLAVE
K870975 · Castle Co. · Apr 1987
RITTER STERILIZER
K801309 · Sybron Corp. · Jun 1980
STERILIZING CASE CAT. NO. 65199
K800080 · Edward Weck, Inc. · Jan 1980