Cleared Traditional

K910778 - STEAM VACUUM PULSE STERILIZER SYSTEM (SVPSS)

K910778 is an FDA 510(k) clearance for STEAM VACUUM PULSE STERILIZER SYSTEM (S..., manufactured by Mdt Biologic Co.. The device is a Class 2 General Hospital device with product code FLE cleared through the Traditional 510(k) pathway after a 248-day FDA review.

K910778 · Mdt Biologic Co. · General Hospital
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Oct 1991
Decision
248d
Days
Class 2
Risk

K910778 is an FDA 510(k) clearance for the STEAM VACUUM PULSE STERILIZER SYSTEM (SVPSS). Classified as Sterilizer, Steam (product code FLE), Class II - Special Controls.

Submitted by Mdt Biologic Co. (Rochester, US). The FDA issued a Cleared decision on October 28, 1991 after a review of 248 days - an extended review 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: 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 Mdt Biologic Co. devices

FDA 510(k) Submission Details - K910778

510(k) Number K910778 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 1991
Decision Date October 28, 1991
Days to Decision 248 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
119d slower than avg
Panel avg: 129d · This submission: 248d
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 106
Devices cleared under the same product code (FLE) and FDA review panel - the closest regulatory comparables to K910778.
MDT/HARVEY MC-8 AND MC-10
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EAGLE 3000 SDS
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DAVIS AND GECK HANDHELD INST. STERILIZATION TRAY
K920293 · Davis & Geck, Inc. · Apr 1992
KAVOKLAVE STEAM AUTOCLAVE
K910789 · Kavo America · Aug 1991
MODEL #M9 ULTRACLAVE STEAM STERILIZER
K911322 · Midmark Corp. · Aug 1991
MODEL #M8 ELECTRONIC STERILIZER
K900432 · Midmark Corp. · Jul 1990