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

Salt Lake City, UT, US

Dynasthetics appears in FDA device records in Salt Lake City, UT. FDA records list one 510(k) clearance, no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
1
PMA records
0
Recall records
1
Registered establishments
1

510(k) clearance history

FDA records hold 1 510(k) clearance for Dynasthetics in 2022.

Clearances by year, as a table
510(k) clearance decisions for Dynasthetics, by decision year
YearClearances
20221
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K220591ProximaNFBSubstantially Equivalent

Registered establishments

FDA registered establishments for Dynasthetics, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30087767803008776780Dynasthetics3487 W 2100 S 300, Salt Lake City, UT 84119 US2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-1591-2023Vapor-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 an anesthesia delivery system to prevent unwanted anesthetic vapors emanating from within an anesthesia gas machine from reaching a patient.Due to a manufacturing issue that may result in filter leakage.Class IIOpen, Classified

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain