Cleared Traditional

K895856 - MEDISYSTEMS TRANSDUCER PROTECTOR

K895856 is an FDA 510(k) clearance for MEDISYSTEMS TRANSDUCER PROTECTOR, manufactured by Medisystems Corp.. The device is a Class 2 Gastroenterology & Urology device with product code FIB cleared through the Traditional 510(k) pathway after a 53-day FDA review.

K895856 · Medisystems Corp. · Gastroenterology & Urology device
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Nov 1989
Decision
53d
Days
Class 2
Risk

K895856 is an FDA 510(k) clearance for the MEDISYSTEMS TRANSDUCER PROTECTOR. Classified as Protector, Transducer, Dialysis (product code FIB), Class II - Special Controls.

Submitted by Medisystems Corp. (San Francisco, US). The FDA issued a Cleared decision on November 24, 1989 after a review of 53 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5820 - the FDA gastroenterology and urology 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 - K895856

510(k) Number K895856 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 1989
Decision Date November 24, 1989
Days to Decision 53 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
78d faster than avg
Panel avg: 131d · This submission: 53d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FIB Device Classification - Class 2, Special Controls

Product Code FIB Protector, Transducer, Dialysis
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5820
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 Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - FIB Protector, Transducer, Dialysis

All 34
Devices cleared under the same product code (FIB) and FDA review panel - the closest regulatory comparables to K895856.
TRANSDUCER PROTECTOR
K901409 · Filtertek, Inc. · Jul 1990
FILTERTEK PN 60650 DIALYSIS TRANSDUCER PROTECTOR
K901996 · Filtertek, Inc. · Jun 1990
HEMODIALYSIS TRANSDUCER PROTECTOR
K900841 · Mediflex Intl. · May 1990
TRANSDUCER PROTECTOR
K895281 · Filtertek, Inc. · Nov 1989
DA-46 FLUID BARRIER
K891752 · Akcess Medical Products, Inc. · Apr 1989
HYDROPHOBIC #6194418/HYDRAPHILIC #6104418 FILTERS
K870394 · Clinical Connections, Inc. · Mar 1987
K895856 · MEDISYSTEMS TRANSDUCER PROTECTOR
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