Cleared Traditional

K970536 - MEDISYSTEMS TRANDUCER PROTECTOR

K970536 is an FDA 510(k) clearance for MEDISYSTEMS TRANDUCER 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 89-day FDA review.

K970536 · Medisystems Corp. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1997
Decision
89d
Days
Class 2
Risk

K970536 is an FDA 510(k) clearance for the MEDISYSTEMS TRANDUCER PROTECTOR. Classified as Protector, Transducer, Dialysis (product code FIB), Class II - Special Controls.

Submitted by Medisystems Corp. (Seattle, US). The FDA issued a Cleared decision on May 12, 1997 after a review of 89 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.

View all Medisystems Corp. devices

FDA 510(k) Submission Details - K970536

510(k) Number K970536 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 1997
Decision Date May 12, 1997
Days to Decision 89 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 131d · This submission: 89d
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 16
Devices cleared under the same product code (FIB) and FDA review panel - the closest regulatory comparables to K970536.
BORLA TRANSDUCER PROTECTOR & HAEMOTRONIC TRANSDUCER PROTECTOR
K000702 · Fresenius Medical Care North America · Jun 2000
MEDISYSTEMS TRANSDUCER PROTECTOR
K983076 · Medisystems Corp. · Nov 1998
BETTER-BLADDER (BB)
K964337 · Circulatory Technology, Inc. · May 1997
MILLEX, DUALEX (PLUS, ULTRA)
K934069 · Millipore Corp. · Apr 1994
TRANSDUCER PROTECTOR
K910821 · Gelman Sciences, Inc. · Aug 1991
MEDISYSTEMS TRANSDUCER PROTECTOR
K895856 · Medisystems Corp. · Nov 1989