Cleared Special

K070657 - GETINGE 633HC SERIES VACUUM/GRAVITY STEAM STERILIZER

K070657 is an FDA 510(k) clearance for GETINGE 633HC SERIES VACUUM/GRAVITY STE..., manufactured by Getinge Sourcing, LLC. The device is a Class 2 General Hospital device with product code FLE cleared through the Special 510(k) pathway after a 27-day FDA review.

K070657 · Getinge Sourcing, LLC · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2007
Decision
27d
Days
Class 2
Risk

K070657 is an FDA 510(k) clearance for the GETINGE 633HC SERIES VACUUM/GRAVITY STEAM STERILIZER. Classified as Sterilizer, Steam (product code FLE), Class II - Special Controls.

Submitted by Getinge Sourcing, LLC (Rochester, US). The FDA issued a Cleared decision on April 5, 2007 after a review of 27 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K070657

510(k) Number K070657 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 2007
Decision Date April 05, 2007
Days to Decision 27 days
Submission Type Special
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
102d faster than avg
Panel avg: 129d · This submission: 27d
Pathway characteristics
Modification to existing cleared device.

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 153
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