Cleared Traditional

K910821 - TRANSDUCER PROTECTOR

K910821 is an FDA 510(k) clearance for TRANSDUCER PROTECTOR, manufactured by Gelman Sciences, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FIB cleared through the Traditional 510(k) pathway after a 167-day FDA review.

K910821 · Gelman Sciences, Inc. · Gastroenterology & Urology device
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Aug 1991
Decision
167d
Days
Class 2
Risk

K910821 is an FDA 510(k) clearance for the TRANSDUCER PROTECTOR. Classified as Protector, Transducer, Dialysis (product code FIB), Class II - Special Controls.

Submitted by Gelman Sciences, Inc. (Ann Arbor, US). The FDA issued a Cleared decision on August 12, 1991 after a review of 167 days - an extended review 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: 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 Gelman Sciences, Inc. devices

FDA 510(k) Submission Details - K910821

510(k) Number K910821 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 1991
Decision Date August 12, 1991
Days to Decision 167 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
36d slower than avg
Panel avg: 131d · This submission: 167d
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 K910821.
BETTER-BLADDER (BB)
K964337 · Circulatory Technology, Inc. · May 1997
MEDISYSTEMS TRANDUCER PROTECTOR
K970536 · Medisystems Corp. · May 1997
MILLEX, DUALEX (PLUS, ULTRA)
K934069 · Millipore Corp. · Apr 1994
MEDISYSTEMS TRANSDUCER PROTECTOR
K895856 · Medisystems Corp. · Nov 1989
DA-46 FLUID BARRIER
K891752 · Akcess Medical Products, Inc. · Apr 1989
GAMBRO PRESSURE MONITOR GUARDS
K851230 · Gambro, Inc. · Apr 1985