Data / Medical devices / United States / Dynasthetics

Dynasthetics: FDA-registered device maker in Salt Lake City, UT, United States, 2 510(k) clearances

Name: Dynasthetics FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Dynasthetics is registered with the FDA (registration 3008776780) in Salt Lake City, UT, United States. It lists 4 device types. The FDA files 2 510(k) clearances under its listings, the newest dated December 15, 2022. 1 recall event names it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3008776780
Address: 4694 S 200 W, Salt Lake City, UT, United States, 84107
Owner or operator: Dynasthetics (10034175)
Roles: Manufacturer
First device listed: November 11, 2010
Registered through: 2027
Brand names listed: SmartProngs, Sovant, Vapor-Clean, VeyO2

Devices it lists

Device	Product code	Class	Role	Source
Apparatus, Gas-Scavenging	CBN	2	Manufacturer	accessdata.fda.gov
Cannula, Nasal, Oxygen	CAT	1	Manufacturer	accessdata.fda.gov
Conserver, Oxygen	NFB	2	Manufacturer	accessdata.fda.gov
Mask, Oxygen	BYG	1	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
December 15, 2022	K220591	Proxima	NFB	Substantially Equivalent	Dynasthetics, LLC	accessdata.fda.gov
April 16, 2010	K092031	VAPOR-CLEAR, MODEL 100	CBN	Substantially Equivalent	Axon Medical, Inc.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
May 9, 2022	92026	Class II	Ongoing	Vapor-Clean, Part Number 111AU The Vapor-Clean filter is intended to be used to remove unwanted anesthetic gases from the patient breathing circuit. The device uses two anesthetic vapor adsorbent canisters connected to a	Due to a manufacturing issue that may result in filter leakage.	accessdata.fda.gov

Compare with other makers

Updated May 16, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.