510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K780703Substantially Equivalent

Cuff Pacer

Omp Laboratories, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K780703 is the FDA 510(k) clearance record for CUFF PACER, a class II device, cleared for Omp Laboratories, Inc. on under FDA product code CBA (Monitor, Air Embolism, Ultrasonic). FDA records list 2 510(k) clearances for Omp Laboratories, Inc., from to . As of , FDA records show no recalls naming K780703.

Clearance record

Decision date
Received
(83 days to decision)
Product code
CBA Monitor, Air Embolism, Ultrasonic
Regulation
21 CFR 868.2025
Device class
Class II
Review panel
Anesthesiology
Applicant
Omp Laboratories, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code CBA

Trailing 12 months

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

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