Cleared Traditional

K954736 - ACCESS (POWERCLAVE)

K954736 is an FDA 510(k) clearance for ACCESS (POWERCLAVE), 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 304-day FDA review.

K954736 · Mdt Biologic Co. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1996
Decision
304d
Days
Class 2
Risk

K954736 is an FDA 510(k) clearance for the ACCESS (POWERCLAVE). 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 August 15, 1996 after a review of 304 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: Standard predicate-based submission. Elevated predicate reliance profile. 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 - K954736

510(k) Number K954736 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 16, 1995
Decision Date August 15, 1996
Days to Decision 304 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
175d slower than avg
Panel avg: 129d · This submission: 304d
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 K954736.
STERILEMAX
K953938 · Barnstead/Thermolyne Corp. · Jan 1997
STAT IM 5000 CASSETTE AUTOCLAVE
K962179 · Scican · Jan 1997
STERIMASTER AUTOCLAVE
K944036 · Scican · Oct 1996
EASTERCLAVE
K961230 · Easter Services, Inc. · Jun 1996
MIDMARK M-11 ULTRACLAVE STEAM STERILIZER
K936181 · Midmark Corp. · Nov 1994
MDT/HARVEY MC-8 AND MC-10
K924955 · Mdt Corp., Inc. · Oct 1993