Cleared Traditional

BARD (R) ESKA ERECTIOMETER (K880903) - FDA 510(k) Clearance

K880903 · C.R. Bard, Inc. · Gastroenterology & Urology device
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May 1988
Decision
65d
Days
-
Risk

K880903 is an FDA 510(k) clearance for the BARD (R) ESKA ERECTIOMETER. Classified as Monitor, Penile Tumescence (product code LIL).

Submitted by C.R. Bard, Inc. (Covington, US). The FDA issued a Cleared decision on May 6, 1988 after a review of 65 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel. 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 C.R. Bard, Inc. devices

Submission Details

510(k) Number K880903 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 1988
Decision Date May 06, 1988
Days to Decision 65 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
65d faster than avg
Panel avg: 130d · This submission: 65d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LIL Monitor, Penile Tumescence
Device Class -