Cleared Traditional

K895275 - MAC LAVE STEAM STERILIZER

K895275 is an FDA 510(k) clearance for MAC LAVE STEAM STERILIZER, manufactured by Merchants Export Development Corp.. The device is a Class 2 General Hospital device with product code FLE cleared through the Traditional 510(k) pathway after a 457-day FDA review.

K895275 · Merchants Export Development Corp. · General Hospital
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Nov 1990
Decision
457d
Days
Class 2
Risk

K895275 is an FDA 510(k) clearance for the MAC LAVE STEAM STERILIZER. Classified as Sterilizer, Steam (product code FLE), Class II - Special Controls.

Submitted by Merchants Export Development Corp. (Indianapolis, US). The FDA issued a Cleared decision on November 23, 1990 after a review of 457 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Merchants Export Development Corp. devices

FDA 510(k) Submission Details - K895275

510(k) Number K895275 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 1989
Decision Date November 23, 1990
Days to Decision 457 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
328d slower than avg
Panel avg: 129d · This submission: 457d
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 137
Devices cleared under the same product code (FLE) and FDA review panel - the closest regulatory comparables to K895275.
DAVIS AND GECK HANDHELD INST. STERILIZATION TRAY
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MODEL #M9 ULTRACLAVE STEAM STERILIZER
K911322 · Midmark Corp. · Aug 1991
MODEL #M8 ELECTRONIC STERILIZER
K900432 · Midmark Corp. · Jul 1990
PRESSURE STEAM STERILIZERS
K895848 · Scientific Device Laboratory, Inc. · Dec 1989
MITEK STERILIZATION TRAY
K893886 · Mitek Surgical Products, Inc. · Aug 1989