510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K001714Substantially Equivalent

Mercury Medical Hyperinflation Bag System, Model 83-900-0149

Mercury Medical, Clearwater FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K001714 is the FDA 510(k) clearance record for MERCURY MEDICAL HYPERINFLATION BAG SYSTEM, MODEL 83-900-0149, a class II device, cleared for Mercury Medical on under FDA product code NHK (Resuscitator, Manual, Non Self-Inflating). FDA's definition for product code NHK reads: "A non self-inflating manual resuscitator, also called a hyperinflation system, is a manual ventilator intended to ventilate a patient by forcing a volume of fresh gas into the patient via compression of the ventilator bag; a source of...". FDA records list 16 510(k) clearances for Mercury Medical, from to . As of , FDA records show no recalls naming K001714.

Clearance record

Decision date
Received
(151 days to decision)
Product code
NHK Resuscitator, Manual, Non Self-Inflating
Regulation
21 CFR 868.5905
Device class
Class II
Review panel
Anesthesiology
Applicant
Mercury Medical 11300 49th St. N., Clearwater FL
510(k) summary
Summary
Third party review
No

Clearances, product code NHK

Trailing 12 months

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

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