Cleared Traditional

K944036 - STERIMASTER AUTOCLAVE

K944036 is an FDA 510(k) clearance for STERIMASTER AUTOCLAVE, manufactured by Scican. The device is a Class 2 General Hospital device with product code FLE cleared through the Traditional 510(k) pathway after a 776-day FDA review.

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

FDA 510(k) Submission Details - K944036

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
Combination Product No
PCCP Authorized No
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.

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 105
Devices cleared under the same product code (FLE) and FDA review panel - the closest regulatory comparables to K944036.
DELTA
K945117 · Pelton & Crane Co. · Feb 1997
STERILEMAX
K953938 · Barnstead/Thermolyne Corp. · Jan 1997
STAT IM 5000 CASSETTE AUTOCLAVE
K962179 · Scican · Jan 1997
ACCESS (POWERCLAVE)
K954736 · Mdt Biologic Co. · Aug 1996
EASTERCLAVE
K961230 · Easter Services, Inc. · Jun 1996
MIDMARK M-11 ULTRACLAVE STEAM STERILIZER
K936181 · Midmark Corp. · Nov 1994