Cleared Traditional

K000702 - BORLA TRANSDUCER PROTECTOR & HAEMOTRONI...

K000702 is the FDA 510(k) clearance for BORLA TRANSDUCER PROTECTOR & HAEMOTRONI... by Fresenius Medical Care North America. It is a Class 2 Gastroenterology & Urology device (product code FIB) cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K000702 · Fresenius Medical Care North America · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2000
Decision
98d
Days
Class 2
Risk

K000702 is an FDA 510(k) clearance for the BORLA TRANSDUCER PROTECTOR & HAEMOTRONIC TRANSDUCER PROTECTOR. Classified as Protector, Transducer, Dialysis (product code FIB), Class II - Special Controls.

Submitted by Fresenius Medical Care North America (Lexington, US). The FDA issued a Cleared decision on June 7, 2000 after a review of 98 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Fresenius Medical Care North America devices

Submission Details

510(k) Number K000702 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 2000
Decision Date June 07, 2000
Days to Decision 98 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
32d faster than avg
Panel avg: 130d · This submission: 98d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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

Devices cleared under the same product code (FIB) and FDA review panel - the closest regulatory comparables to K000702.
NovaLine SP-C35 Transducer Protector (956007)
K240164 · Bain Medical Equipment (Guangzhou) Co., Ltd. · Jun 2024
NIPRO TRANSDUCER PROTECTOR TP-SURE, MODEL TPSURE+1
K072988 · Nipro Medical Corporation · Feb 2008
FRESENIUS VIRAL BLOCKING TRANSDUCER PROTECTOR FOR HEMODIALYSIS, MODEL 04-9500-2
K003445 · Fresenius Medical Care North America · Dec 2000
DA-46 FLUID BARRIER
K891752 · Akcess Medical Products, Inc. · Apr 1989
GAMBRO PRESSURE MONITOR GUARDS
K851230 · Gambro, Inc. · Apr 1985
CORDIS DOW SERA FLO TM TRANSDUCER PROT
K811892 · Cordis Corp. · Jul 1981