Sorenson Medical, Inc.
West Jordan, UT, US
Sorenson Medical, Inc. appears in FDA device records in West Jordan, UT. FDA records list 6 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show 6 recalls for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 6 510(k) clearances for Sorenson Medical, Inc. between 1999 and 2005. The busiest year on record is 2000, with 2. The most recent is 2005, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1999 | 1 |
| 2000 | 2 |
| 2003 | 2 |
| 2005 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K052221 | AMBIT PUSH & PLAY AMBULATORY INFUSION PUMP | FRN | Substantially Equivalent | |
| K033425 | AMBIT INTERMITTENT AMBULATORY INFUSION PUMP | FRN | Substantially Equivalent | |
| K033325 | AMBIT CONTINUOUS AMBULATORY INFUSION PUMP | FRN | Substantially Equivalent | |
| K002434 | PALM PUMP | MEA | Substantially Equivalent | |
| K001287 | EMPTY RESERVOIR BAG, 50 ML,100 ML,250 ML,500 ML, 1000M ML, 1500 ML, 2000 ML, 3000 ML | KPE | Substantially Equivalent | |
| K991363 | 30 PUMP, CONTINUOUS LOW FLOW, 200 PUMP, INTERMITTENT WITH KVO OR CONTINUOUS, PCA PUMP, PAIN MANAGEMENT, PCEA PUMP, EPIDU | FRN | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0188-2007 | ambIT Ambulatory Infusion Pump Cassette; Filterless, Male, Sterile, Vol. 2.3ml, REF 220267, Sorenson Medical, Inc., West Jordan, Utah. | Sterile disposable cassette used with infusion pump may cause an under-infusion when used in a low flow rate therapy of less than 10 ml per hour. | Terminated | ||
| Z-0187-2007 | ambIT Ambulatory Infusion Pump Cassette; Filter, Male, Sterile, Vol. 2.3ml, REF 220266, Sorenson Medical, Inc., West Jordan, Utah. | Sterile disposable cassette used with infusion pump may cause an under-infusion when used in a low flow rate therapy of less than 10 ml per hour. | Terminated | ||
| Z-0186-2007 | ambIT Ambulatory Infusion Pump Cassette; Filter, Spike, Sterile, Vol. 2.3ml, REF 220140, Sorenson Medical, Inc., West Jordan, Utah. | Sterile disposable cassette used with infusion pump may cause an under-infusion when used in a low flow rate therapy of less than 10 ml per hour. | Terminated | ||
| Z-0185-2007 | ambIT Ambulatory Infusion Pump Cassette; Filterless, Spike, Sterile, Vol. 2.3ml, REF 220139, Sorenson Medical, Inc., West Jordan, Utah | Sterile disposable cassette used with infusion pump may cause an under-infusion when used in a low flow rate therapy of less than 10 ml per hour. | Terminated | ||
| Z-1188-06 | ambIT Ambulatory Infusion Therapy Intermittent Pump | Intermittent Infusion pump may continually dispense medication under certain conditions. | Terminated | ||
| Z-0496-03 | Trach-Eze Closed Suction System Endotracheal Start Kit *** 16F *** REF 220070 *** Catheter Length: 571 mm *** STERILE ***. | Catheters have 2 unvalidated seal product configurations to produce a new hybrid seal that had not been verified or validated. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain