People should rely on the well-established Heimlich maneuver to save a choking victim, rather than newfangled “anti-choking” devices, the U.S. Food and Drug Administration says.

“The safety and effectiveness of over-the-counter anti-choking devices have not been established; they are not FDA approved or cleared,” the agency said in a safety communication issued Monday.

The FDA admitted that it is “not aware of any serious injuries reported with the use of these devices, and no deaths have been associated with the use of anti-choking devices."

However, the agency is concerned that fumbling with these one-use-only devices could cost precious time in an emergency.

“Consumers should be aware that using anti-choking devices first could delay action, as consumers usually have to take them out of packaging, assemble them and follow device instructions, which may delay the use of established rescue protocols,” the agency said.

Lack of oxygen to the brain for more than four minutes can cause brain damage and death, according to Johns Hopkins Medicine.

The Heimlich maneuver works by applying abdominal thrusts to a choking victim. These thrusts force air out of the lungs and up through the throat, dislodging the object that’s obstructing the airway.

By comparison, anti-choking devices are designed to suck out an object that’s obstructing a person’s airways, using vacuum pressure.

The leading device, the $70 LifeVac, comes with a mask that fits over a person’s nose or mouth and attaches to a plunger-like bellows. Pushing the bellows down and then quickly up creates a vacuum to clear the airway.

The LifeVac website contains a “Hall of Saves” presenting thousands of cases in which the device has saved a child or adult from choking, as well as a page devoted to medical journal articles about the gadget.

The company informs consumers that the LifeVac is “FDA registered as a Class II medical device.”

“It is exempt from pre-market clearance. The FDA does not require a pre-market review of the LifeVac device,” the website says. “Currently, in the United States, all portable suction devices are required to be registered with the FDA, not approved.”

Still, the FDA says people should not rely on these devices because established choking rescue protocols, which rely on the Heimlich, “have a high rate of success and can be carried out immediately without devices, saving valuable time.” 

These protocols are designed to save the lives of adults, children and even babies who are choking. People also can perform a Heimlich on themselves, using the back of a chair or the edge of a counter.

“If you choose to use an anti-choking device, only use it after established choking rescue protocols have failed,” the FDA added. “The safety and effectiveness of over-the-counter anti-choking devices have not been established.”