Cleared Traditional

K072466 - STATIM 7000 (WITHOUT USB PORT), MODEL 01-702100, STATIM 7000 (WITH USB PORT), MODEL 01-702101

K072466 is an FDA 510(k) clearance for STATIM 7000 (WITHOUT USB PORT), manufactured by Scican , Ltd.. The device is a Class 2 General Hospital device with product code FLE cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K072466 · Scican , Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2007
Decision
106d
Days
Class 2
Risk

K072466 is an FDA 510(k) clearance for the STATIM 7000 (WITHOUT USB PORT), MODEL 01-702100, STATIM 7000 (WITH USB PORT),.... Classified as Sterilizer, Steam (product code FLE), Class II - Special Controls.

Submitted by Scican , Ltd. (Toronto, CA). The FDA issued a Cleared decision on December 19, 2007 after a review of 106 days - within the typical 510(k) review window.

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: 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 Scican , Ltd. devices

FDA 510(k) Submission Details - K072466

510(k) Number K072466 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 2007
Decision Date December 19, 2007
Days to Decision 106 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
23d faster than avg
Panel avg: 129d · This submission: 106d
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 144
Devices cleared under the same product code (FLE) and FDA review panel - the closest regulatory comparables to K072466.
PRIMUS STEAM STERILIZER, MODELS PSS5-G-1 AND PSS5-M
K082817 · Primus Sterilizer Company, LLC · May 2009
BRAVO AUTOCLAVE, MODELS 17, 17V AND 21V
K090265 · Scican , Ltd. · May 2009
AMSCO EVOLUTION MEDIUM STEAM STERILIZER
K082435 · STERIS Corporation · Dec 2008
BELIMED STEAM STERILIZER MODEL TOP 5000 SERIES 24
K072087 · Belimed Sauter AG · Oct 2007
TECNO-GAZ ANDROMEDA VACUUM CS AUTOCLAVE
K063681 · Mediline Italia S.R.L. · Jun 2007
GETINGE 633HC SERIES VACUUM/GRAVITY STEAM STERILIZER
K070657 · Getinge Sourcing, LLC · Apr 2007