Data / Medical devices / United States / Sechrist Industries, Inc.
Sechrist Industries, Inc.: FDA-registered device maker in Anaheim, CA, United States, 8 510(k) clearances
Sechrist Industries, Inc. is registered with the FDA (registration 2020676) in Anaheim, CA, United States. It lists 8 device types. The FDA files 8 510(k) clearances under its listings, the newest dated May 30, 2014. 5 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 2020676
- Address
- 4225 E La Palma Ave, Anaheim, CA, United States, 92807
- Owner or operator
- SECHRIST INDUSTRIES, INC. (2020676)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- December 13, 2007
- Registered through
- 2026
- Brand names listed
- 3500 Series Air/Oxygen Mixer, 3500CP-G Air/Oxygen Mixer, EZ Load Hydraulic Gurney, Electric (E-Gurney) Wheeled Stretcher, HBO Cable assembly, radiometer, HBO Demand Valve Assembly, Hydraulic Gurney, Hyperbaric Electronic Records Organizer (H.E.R.O.) and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Chamber, Hyperbaric | CBF | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Gas Control Unit, Cardiopulmonary Bypass | DTX | 2 | Manufacturer | accessdata.fda.gov |
| Medical Device Data System | OUG | 1 | Manufacturer | accessdata.fda.gov |
| Mixer, Breathing Gases, Anesthesia Inhalation | BZR | 2 | Manufacturer | accessdata.fda.gov |
| Monitor, Carbon-Dioxide, Cutaneous | LKD | 2 | Manufacturer | accessdata.fda.gov |
| Stretcher, Wheeled | FPO | 2 | Manufacturer | accessdata.fda.gov |
| Valve, Non-Rebreathing | CBP | 2 | Manufacturer | accessdata.fda.gov |
| Ventilator, Continuous, Facility Use | CBK | 2 | 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 |
|---|---|---|---|---|---|---|
| May 30, 2014 | K140559 | SECHRIST MONOPLACE HYPERBARIC OXYGEN CHAMBER | CBF | Substantially Equivalent | Sechrist Industries, Inc. | accessdata.fda.gov |
| April 26, 2010 | K100268 | SECHRIST MONOPLACE HYPERBARIC OXYGEN CHAMBER | CBF | Substantially Equivalent | Sechrist Industries, Inc. | accessdata.fda.gov |
| October 28, 2005 | K052713 | MODEL 3300E/ER MONOPLACE HYPERBARIC OXYGEN CHAMBER | CBF | Substantially Equivalent | Sechrist Industries, Inc. | accessdata.fda.gov |
| January 17, 2003 | K023745 | SECHRIST AIR/OXYGEN MIXER, MODEL 3500 CP-G | DTX | Substantially Equivalent | Sechrist Industries, Inc. | accessdata.fda.gov |
| August 10, 1999 | K992503 | SECHRIST AIR-OXYGEN MIXER, 3500/3500HL SERIES | BZR | Substantially Equivalent | Sechrist Industries, Inc. | accessdata.fda.gov |
| June 13, 1995 | K950386 | MODEL 3200P/3200PR HYPERBARIC CHAMBER | CBF | Substantially Equivalent | Sechrist Industries, Inc. | accessdata.fda.gov |
| April 10, 1991 | K905225 | HBO CABLE ASSEMBLY, RADIOMETER TC-02 | LKD | Substantially Equivalent | Sechrist | accessdata.fda.gov |
| December 13, 1988 | K884543 | LSP DEMAND INHALATOR VALVE MODEL SPOO68 W/MASK | CBP | Substantially Equivalent | Sechrist Industries, 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 |
|---|---|---|---|---|---|---|
| June 1, 2015 | 71455 | Class II | Terminated | Sechrist Low Profile Wheeled Stretcher, Model No. 21762-110-33H, 21762-110-36H, 21762-110-41H, 21762-135-33HJ, 21762-010-36H, 21762-010-41H, 21762-111-36H. | Sechrist Industries is recalling the Sechrist Low Profile Wheeled Stretcher because it may experience an unexpected incline angle during the height adjustment of the Low Profile Wheeled Stretcher when lifting the patient upward or when lowering the Wheeled Stretcher to a height at which the patient can be loaded/unloaded. | accessdata.fda.gov |
| September 15, 2009 | 60466 | Not yet classified | Terminated | Sechrist Hyperbaric Chamber Gurney. The Sechrist Hyperbaric Chamber Gurney is an accessory device to the Sechrist Monoplace Hyperbaric Chambers. It is intended solely for the loading and unloading of patients into Sechri | Stryker Medical has received complaints from customers that indicate a bushing in the braking system may fracture, which could result in the brake/steer pedal seizing. If the pedal seizes, the braking system may become inoperable or steering around corners may come more difficult. While no injuries have been associated with these reported events nor has ther | accessdata.fda.gov |
| August 28, 2008 | 52796 | Class II | Terminated | Sechrist Monoplace Hyperbaric Chamber with Electronic Control Module Model 3300E/ER The Hyperbaric Chamber is intended to provide 100% oxygen to the patient at greater than ambient pressures. | Sechrist conducted a field upgrade on the hyperbaulic chambers equipped with Electronic Control Modules in order to correct a software bug that could potentially affect the performance of the chamber. | accessdata.fda.gov |
| October 31, 2007 | 45906 | Not yet classified | Terminated | Sechrist Hyperbaric Chamber Gurney, Standard Gurney & Stretcher Model, P/N : 21502, Sechrist Industries, Inc., Anaheim, CA | Brake Problems: The stretcher brake cams may crack while attempting to lock the stretcher brake (Sechrist is supplied the stretchers by the manufacturer Stryker Medical) | accessdata.fda.gov |
| May 20, 2004 | 29228 | Not yet classified | Terminated | Infant Ventilators with Electronic Manometer. Models IV-100B; IV-200 and IV-200 SAVI. | Electronic manometer malfunctions. Manometer may be illegible. The alarm for power failure may function only briefly, or not at all. | accessdata.fda.gov |
Compare with other makers
- All makers of Chamber, Hyperbaric
- All makers of Valve, Non-Rebreathing
- All makers of Stretcher, Wheeled
- All makers of Mixer, Breathing Gases, Anesthesia Inhalation
- All makers of Monitor, Carbon-Dioxide, Cutaneous
- All makers of Medical Device Data System
Updated July 1, 2015. 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.