Cleared Traditional

STERIMASTER AUTOCLAVE (K944036) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K944036 · Scican · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1996
Decision
776d
Days
Class 2
Risk

K944036 is an FDA 510(k) clearance for the STERIMASTER AUTOCLAVE. Classified as Sterilizer, Steam (product code FLE), Class II - Special Controls.

Submitted by Scican (Toronto, CA). The FDA issued a Cleared decision on October 2, 1996 after a review of 776 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 Scican devices

Submission Details

510(k) Number K944036 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 1994
Decision Date October 02, 1996
Days to Decision 776 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
647d slower than avg
Panel avg: 129d · This submission: 776d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 183
Devices cleared under the same product code (FLE) and FDA review panel - the closest regulatory comparables to K944036.
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