Cleared Traditional

K072988 - NIPRO TRANSDUCER PROTECTOR TP-SURE

K072988 is the FDA 510(k) clearance for NIPRO TRANSDUCER PROTECTOR TP-SURE by Nipro Medical Corporation. It is a Class 2 Gastroenterology & Urology device (product code FIB) cleared through the Traditional 510(k) pathway after a 121-day FDA review.

K072988 · Nipro Medical Corporation · Gastroenterology & Urology device
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Feb 2008
Decision
121d
Days
Class 2
Risk

K072988 is an FDA 510(k) clearance for the NIPRO TRANSDUCER PROTECTOR TP-SURE, MODEL TPSURE+1. Classified as Protector, Transducer, Dialysis (product code FIB), Class II - Special Controls.

Submitted by Nipro Medical Corporation (Miami, US). The FDA issued a Cleared decision on February 21, 2008 after a review of 121 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 Nipro Medical Corporation devices

Submission Details

510(k) Number K072988 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 2007
Decision Date February 21, 2008
Days to Decision 121 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
9d faster than avg
Panel avg: 130d · This submission: 121d
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 K072988.
NovaLine SP-C35 Transducer Protector (956007)
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