Cleared Traditional

K920409 - DACOMED BATTERY OPERATED VACUUM ERECTION DEVICE

K920409 is an FDA 510(k) clearance for DACOMED BATTERY OPERATED VACUUM ERECTIO..., manufactured by Dacomed Corp.. The device is a Class 2 Gastroenterology & Urology device with product code LKY cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K920409 · Dacomed Corp. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1992
Decision
101d
Days
Class 2
Risk

K920409 is an FDA 510(k) clearance for the DACOMED BATTERY OPERATED VACUUM ERECTION DEVICE. Classified as Device, External Penile Rigidity (product code LKY), Class II - Special Controls.

Submitted by Dacomed Corp. (Minneapolis, US). The FDA issued a Cleared decision on May 11, 1992 after a review of 101 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5020 - 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 Dacomed Corp. devices

FDA 510(k) Submission Details - K920409

510(k) Number K920409 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 1992
Decision Date May 11, 1992
Days to Decision 101 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
30d faster than avg
Panel avg: 131d · This submission: 101d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LKY Device Classification - Class 2, Special Controls

Product Code LKY Device, External Penile Rigidity
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5020
Definition Intended To Create Or Maintain Sufficient Penile Rigidity For Sexual Intercourse. These Include Vacuum Pumps, Constriction Rings, And Penile Splints, Which Are Mechanical, Powered Or Pneumatic Devices.
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 - LKY Device, External Penile Rigidity

All 42
Devices cleared under the same product code (LKY) and FDA review panel - the closest regulatory comparables to K920409.
POS-T-VAC B-10 BAND KIT
K960828 · Pos-T-Vac, Inc. · Mar 1996
POS-T-VAC AVP-1000 & MVP-700
K960342 · Pos-T-Vac, Inc. · Mar 1996
TEX-AID BLUE
K955856 · Laborie Medical Technologies, Ltd. · Feb 1996
SURGITEK ERECTEK TM EXTERNAL ERECTION DEVICE
K905015 · Surgitek · Dec 1990
DACOMED NEGATIVE PRESSURE ERECTION DEVICE
K900774 · Dacomed Corp. · May 1990