Cleared Traditional

K895848 - PRESSURE STEAM STERILIZERS

K895848 is an FDA 510(k) clearance for PRESSURE STEAM STERILIZERS, manufactured by Scientific Device Laboratory, Inc.. The device is a Class 2 General Hospital device with product code FLE cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K895848 · Scientific Device Laboratory, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1989
Decision
69d
Days
Class 2
Risk

K895848 is an FDA 510(k) clearance for the PRESSURE STEAM STERILIZERS. Classified as Sterilizer, Steam (product code FLE), Class II - Special Controls.

Submitted by Scientific Device Laboratory, Inc. (Glenview, US). The FDA issued a Cleared decision on December 11, 1989 after a review of 69 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 - K895848

510(k) Number K895848 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 1989
Decision Date December 11, 1989
Days to Decision 69 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 129d · This submission: 69d
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 184
Devices cleared under the same product code (FLE) and FDA review panel - the closest regulatory comparables to K895848.
RACK-IT (R)
K903096 · Vengo Industries, Inc. · Oct 1990
MODEL #M8 ELECTRONIC STERILIZER
K900432 · Midmark Corp. · Jul 1990
STEAM STERILIZER (AUTOCLAVE), DENTAL
K895638 · Porter Instrument Co., Inc. · Feb 1990
MITEK STERILIZATION TRAY
K893886 · Mitek Surgical Products, Inc. · Aug 1989
RESUBMITTED STC SERIES 8600 AUTOCLAVE
K890359 · Sterilizer Technologies Corp. · Aug 1989
MULTI-PURPOSE CONTROL SYSTEM
K885140 · Colliers Sterilizer Sales & Service Co., Inc. · Mar 1989
K895848 · PRESSURE STEAM STERILIZERS
Download PDF Scientific Device Lab…