510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K103317Substantially Equivalent

Resuscitation Unit 105

Atom Medical Corporation, Bonita Springs FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K103317 is the FDA 510(k) clearance record for RESUSCITATION UNIT 105, a class II device, cleared for Atom Medical Corporation on under FDA product code BZR (Mixer, Breathing Gases, Anesthesia Inhalation). FDA records list 15 510(k) clearances for Atom Medical Corporation, from to . As of , FDA records show no recalls naming K103317.

Clearance record

Decision date
Received
(161 days to decision)
Product code
BZR Mixer, Breathing Gases, Anesthesia Inhalation
Regulation
21 CFR 868.5330
Device class
Class II
Review panel
Anesthesiology
Applicant
Atom Medical Corporation 24301 Woodsage Dr., Bonita Springs FL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code BZR

Trailing 12 months

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

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