510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K981506Substantially Equivalent

Restore Vacuum Erection Device, Confide Vacuum Erection Device, Pep (Penile Erection Program), Rely Vacuum Erection Dev)

Repro-Med Systems, Inc., New York NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K981506 is the FDA 510(k) clearance record for RESTORE VACUUM ERECTION DEVICE, CONFIDE VACUUM ERECTION DEVICE, PEP (PENILE ERECTION PROGRAM), RELY VACUUM ERECTION DEV), a class II device, cleared for Repro-Med Systems, Inc. on under FDA product code LKY (Device, External Penile Rigidity). FDA's definition for product code LKY reads: "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". FDA records list 6 510(k) clearances for Repro-Med Systems, Inc., from to . As of , FDA records show no recalls naming K981506.

Clearance record

Decision date
Received
(59 days to decision)
Product code
LKY Device, External Penile Rigidity
Regulation
21 CFR 876.5020
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Repro-Med Systems, Inc. 24 Carpenter Rd., New York NY
510(k) summary
Summary
Third party review
No

Clearances, product code LKY

Trailing 12 months

FDA records hold no clearances under product code LKY in the trailing twelve months.

FDA records show no clearances under product code LKY in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LKY, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260