510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K970785Substantially Equivalent

Sims Hyperinflation Bag System

Sims, Fort Myers FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K970785 is the FDA 510(k) clearance record for SIMS HYPERINFLATION BAG SYSTEM, a class II device, cleared for Sims 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 2 510(k) clearances for Sims, from to . As of , FDA records show no recalls naming K970785.

Clearance record

Decision date
Received
(101 days to decision)
Product code
NHK Resuscitator, Manual, Non Self-Inflating
Regulation
21 CFR 868.5905
Device class
Class II
Review panel
Anesthesiology
Applicant
Sims 5100 Tice St., Fort Myers FL
510(k) summary
Statement
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