Cleared Traditional

K832121 - DACOMED SNAP-GAUGE

K832121 · Dacomed Corp. · Gastroenterology & Urology device

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Jul 1983

Decision

18d

Days

Risk

K832121 is an FDA 510(k) clearance for the DACOMED SNAP-GAUGE. Classified as Monitor, Penile Tumescence (product code LIL).

Submitted by Dacomed Corp.. The FDA issued a Cleared decision on July 18, 1983 after a review of 18 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 Dacomed Corp. devices

FDA 510(k) Submission Details - K832121

510(k) Number	K832121 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 30, 1983
Decision Date	July 18, 1983
Days to Decision	18 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

113d faster than avg

Panel avg: 131d · This submission: 18d

Pathway characteristics

Predicate-based equivalence.

LIL Device Classification - Class 0,

Product Code	LIL Monitor, Penile Tumescence
Device Class	-

Regulatory Peers - LIL Monitor, Penile Tumescence

All 12

Devices cleared under the same product code (LIL) and FDA review panel - the closest regulatory comparables to K832121.

BARD (R) ESKA ERECTIOMETER

K880903 · C.R. Bard, Inc. · May 1988

SURGITEK NPT MONITOR

K875333 · Surgitek · Apr 1988

DACOMED RIGISCAN SYSTEM

K841202 · Dacomed Corp. · Jul 1984

TUMISENSOR 1524

K831251 · Life-Tech Intl., Inc. · Jun 1983

TUMISTORE RECORDER 1311

K831252 · Life-Tech Intl., Inc. · May 1983

DACOMED SNAP-GAUGE

K820615 · Dacomed Corp. · Apr 1982

FDA 510(k) Resources - Gastroenterology & Urology

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K832121

Dacomed Corp.

, MD · US

Regulatory profile

20 submissions 20 cleared

100% clearance rate · Active in Gastroenterology & Urology

About This 510(k) Record

This record restructures FDA 510(k) public data into device-level regulatory intelligence - enabling comparison across product codes, clearance pathways, review times and manufacturer patterns.

Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . FDA decision: July 18, 1983. Record added to 510k Database: March 2026. Enriched with classification and manufacturer data: August 2026.

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