Cleared Traditional

K953645 - OLYMPIC PASTEURMATIC SYSTEM

K953645 is an FDA 510(k) clearance for OLYMPIC PASTEURMATIC SYSTEM, manufactured by Olympic Medical Corp.. The device is a Class 2 General Hospital device with product code LDS cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K953645 · Olympic Medical Corp. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1995
Decision
49d
Days
Class 2
Risk

K953645 is an FDA 510(k) clearance for the OLYMPIC PASTEURMATIC SYSTEM. Classified as Device, Pasteurization, Hot Water (product code LDS), Class II - Special Controls.

Submitted by Olympic Medical Corp. (Seattle, US). The FDA issued a Cleared decision on September 22, 1995 after a review of 49 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6991 - 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.

View all Olympic Medical Corp. devices

FDA 510(k) Submission Details - K953645

510(k) Number K953645 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 1995
Decision Date September 22, 1995
Days to Decision 49 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
80d faster than avg
Panel avg: 129d · This submission: 49d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LDS Device Classification - Class 2, Special Controls

Product Code LDS Device, Pasteurization, Hot Water
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6991
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 - LDS Device, Pasteurization, Hot Water

Devices cleared under the same product code (LDS) and FDA review panel - the closest regulatory comparables to K953645.
Cenorin 610 Washer-Pasteurizers/High Level Disinfector and Cenorin 610HT Washer-Pasteurizers/High Level Disinfector
K183444 · Cenorin, LLC · Sep 2019
RELIANCE FAMILY OF WASHER-DISINFECTORS
K983068 · STERIS Corporation · May 2000
OLYMPIX MINI-PASTEURMATIC (58210)
K972193 · Olympic Medical Corp. · Sep 1997
CASTLE 7538 FLOOR LOADING WASHER
K860263 · Castle Co. · Mar 1986
CASTLE 7515 UTENSIL/GLASSWARE WASHER
K844089 · Castle Co. · Jan 1985