510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K082204Substantially Equivalent

Series Sy Disposable Electrosurgical Pad

Salter Labs, Crofton MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K082204 is the FDA 510(k) clearance record for SERIES SY DISPOSABLE ELECTROSURGICAL PAD, a class II device, cleared for Ventlab Corp. on under FDA product code ODR (Electrosurgical Patient Return Electrode). FDA's definition for product code ODR reads: "Ground pad used to finish circuit during electrosurgery. A single use, non-sterile dispersive electrode with a pre-attached cord used to adhere to the patient over the entire pad surface to complete the electrosurgical circuit between the...". FDA records list 74 510(k) clearances for Salter Labs, from to . As of , FDA records show no recalls naming K082204.

Clearance record

Decision date
Received
(8 days to decision)
Product code
ODR Electrosurgical Patient Return Electrode
Regulation
21 CFR 878.4400
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Ventlab Corp. 1676 Village Green Suite A, Crofton MD
510(k) summary
Statement
Third party review
Yes

Clearances, product code ODR

Trailing 12 months

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

FDA records show no clearances under product code ODR in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code ODR, 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