Data / Medical devices / United States / Cutler Campus
Cutler Campus: FDA-registered device maker in North Salt Lake, UT, United States, 1 PMA approval
Cutler Campus is registered with the FDA (registration 3032745446) in North Salt Lake, UT, United States. It lists 1 device type. The FDA files 1 PMA approval under its listings, the newest dated June 30, 1988. 4 recall events name it as the recalling firm (1 Class I). Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3032745446
- Address
- 330 Cutler Dr, North Salt Lake, UT, United States, 84054
- Owner or operator
- BUNNELL INCORPORATED (1719232)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- December 6, 2007
- Registered through
- 2026
- Brand names listed
- Life Pulse High Frequency Ventilator, LifePulse High Frequency Ventilator
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Ventilator, High Frequency | LSZ | 3 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| June 30, 1988 | P850064 | MODEL 203 LIFE PULSE HIGH FREQUENCY VENTILATOR | LSZ | 48 | September 28, 2026 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| November 2, 2022 | 91103 | Class II | Ongoing | 2.5 mm LifePort Endotracheal Tube Adapters 10-pack, Catalog: 9025; and 2.5 mm LifePort Endotracheal Tube Adaptors inside Patient Circuit Kits, Catalog: 938 | Some adaptors, for use with high frequency ventilators, were packaged improperly, and may deform at the tip, which may impair the ability to pass a suction catheter or may affect normal ventilator performance, which may lead to hypercarbia, hypoxia, and gas trapping. | accessdata.fda.gov |
| November 19, 2012 | 63710 | Class I | Terminated | Patient Circuit used with the Life Pulse High Frequency Ventilator. The Patient Circuit is a required disposable component of the Life Pulse High Frequency Ventilator. Model #(s): Individual Patient Circuit - catalog # 9 | Customer complaints received indicate the heater wire insulation can melt, causing a short which creates sparking and smoke, in the circuit close to the humidifier cartridge. Bunnell is recalling all lots of circuits distributed between March 12, 2012 and November 30, 2012. | accessdata.fda.gov |
| October 25, 2010 | 57377 | Not yet classified | Terminated | One Cat. Life Pulse High Frequency Ventilator, Catalog Number: 203A, Manufactured by: Bunnell Incorporated Salt Lake City, Utah, Rx Only. | Product software coding error may compromise patient safety. | accessdata.fda.gov |
| April 4, 2005 | 33938 | Not yet classified | Terminated | Life Pulse High Frequency Ventilator (HFV) | Potential loss of air flow or change in cycling of the ventilator. Valve Drive Regulator Board may not function properly at elevated temperatures. The increase in temperature could cause a reduction of power, causing the solenoid in the valve to function sporadically. | accessdata.fda.gov |
Compare with other makers
Updated September 28, 2026. 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.