Cleared Traditional

K063711 - TUTTNAUER PREVACUUM STEAM HEATED AUTOCLAVE, MODELS 6990 SP-1A, 66120 SP-1A, 69150 SP-2A, 69120 L USA SP-2A, 69180 SP-2HA

K063711 is an FDA 510(k) clearance for TUTTNAUER PREVACUUM STEAM HEATED AUTOCLAVE, manufactured by Tuttnauer Co. , Ltd.. The device is a Class 2 General Hospital device with product code FLE cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K063711 · Tuttnauer Co. , Ltd. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2007
Decision
50d
Days
Class 2
Risk

K063711 is an FDA 510(k) clearance for the TUTTNAUER PREVACUUM STEAM HEATED AUTOCLAVE, MODELS 6990 SP-1A, 66120 SP-1A, 6.... Classified as Sterilizer, Steam (product code FLE), Class II - Special Controls.

Submitted by Tuttnauer Co. , Ltd. (Washington, US). The FDA issued a Cleared decision on February 2, 2007 after a review of 50 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K063711

510(k) Number K063711 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 2006
Decision Date February 02, 2007
Days to Decision 50 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
79d faster than avg
Panel avg: 129d · This submission: 50d
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 177
Devices cleared under the same product code (FLE) and FDA review panel - the closest regulatory comparables to K063711.
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GETINGE 633HC SERIES VACUUM/GRAVITY STEAM STERILIZER
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MILLENNIUM SERIES, INCLUDING MILLENNIUM B, B+, B2 AND BU
K050263 · M.O. Com S.R.L. · Nov 2006
IMAX 9.5 STERILIZERS
K052532 · Dental X Srl · Sep 2006
BELIMED STEAM STERILIZER TOP 5000, MODEL 5-5-9
K060337 · Sauter AG · Mar 2006
K063711 · TUTTNAUER PREVACUUM STEAM HEATED AUTOCLAVE, MODELS 6990 SP-1A, 66120 SP-1A, 69150 SP-2A, 69120 L USA SP-2A, 69180 SP-2HA
Download PDF FDA Summary Tuttnauer Co. , Ltd.