Sechrist Industries Inc
Anaheim, CA, US
SECHRIST INDUSTRIES, INC. appears in FDA device records in Anaheim, CA. FDA records list 23 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 10 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 23 510(k) clearances for Sechrist Industries Inc between 1978 and 2014. The busiest year on record is 1981, with 2. The most recent is 2014, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1978 | 1 |
| 1980 | 1 |
| 1981 | 2 |
| 1982 | 1 |
| 1983 | 1 |
| 1984 | 1 |
| 1985 | 1 |
| 1986 | 1 |
| 1988 | 2 |
| 1989 | 1 |
| 1990 | 1 |
| 1992 | 1 |
| 1993 | 1 |
| 1995 | 2 |
| 1999 | 2 |
| 2003 | 1 |
| 2005 | 1 |
| 2010 | 1 |
| 2014 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K140559 | SECHRIST MONOPLACE HYPERBARIC OXYGEN CHAMBER | CBF | Substantially Equivalent | |
| K100268 | SECHRIST MONOPLACE HYPERBARIC OXYGEN CHAMBER | CBF | Substantially Equivalent | |
| K052713 | MODEL 3300E/ER MONOPLACE HYPERBARIC OXYGEN CHAMBER | CBF | Substantially Equivalent | |
| K023745 | SECHRIST AIR/OXYGEN MIXER, MODEL 3500 CP-G | DTX | Substantially Equivalent | |
| K993167 | MILLENNIUM INFANT VENTILATOR | CBK | Substantially Equivalent - Subject to Tracking Reg. | |
| K992503 | SECHRIST AIR-OXYGEN MIXER, 3500/3500HL SERIES | BZR | Substantially Equivalent | |
| K950386 | MODEL 3200P/3200PR HYPERBARIC CHAMBER | CBF | Substantially Equivalent | |
| K934164 | MODEL 2500E/2500ER HYPERBARIC CHAMBER | CBF | Substantially Equivalent | |
| K930713 | THE INFANT FLOW SYSTEM | CAI | Substantially Equivalent | |
| K914607 | SEHRIST VOLUME VENTILATOR, MODEL 2200B | CBK | Substantially Equivalent | |
| K896269 | SECHRIST VOLUME VENTILATOR MODEL 2200B | CBK | Substantially Equivalent | |
| K895853 | SECHRIST DISPOSABLE INFANT BREATHING CIRCUIT | BZO | Substantially Equivalent | |
| K884543 | LSP DEMAND INHALATOR VALVE MODEL SPOO68 W/MASK | CBP | Substantially Equivalent | |
| K884156 | HYPERBARIC INTRAVENOUS INFUSION EXTENSION SET | FPK | Substantially Equivalent | |
| K861330 | SECHRIST AIRWAY PRESSURE MONITOR MODEL 600 | CAP | Substantially Equivalent | |
| K850740 | SECHRIST VOLUME VENTILATOR MODIFICATION | Substantially Equivalent | ||
| K833982 | MODEL IV 100B-DA INFANT VENTILATOR | CBK | Substantially Equivalent | |
| K832508 | VOLUME VENTILATOR | CBK | Substantially Equivalent | |
| K821930 | SECHRIST MODEL 990 JET VENTILATOR | CBK | Substantially Equivalent | |
| K811141 | SECHRIST INFANT VENTRILATOR MODEL IV-100 | CBK | Substantially Equivalent | |
| K810648 | SECHRIST AIRWAY PRESSURE MONITOR #400 | CAP | Substantially Equivalent | |
| K802226 | SECHRIST SERIES 3500 AIR-OXYGEN MIXER | BZR | Substantially Equivalent | |
| K780188 | INFANT VENTILATOR MODEL 100 | CBK | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2020676 | 2020676 | SECHRIST INDUSTRIES, INC. | 4225 E LA PALMA AVE, Anaheim, CA 92807 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- CBFChamber, Hyperbaric
- CAICircuit, Breathing (W Connector, Adaptor, Y Piece)
- DTXGas Control Unit, Cardiopulmonary Bypass
- OUGMedical Device Data System
- BZRMixer, Breathing Gases, Anesthesia Inhalation
- CAPMonitor, Airway Pressure (Includes Gauge And/Or Alarm)
- LKDMonitor, Carbon-Dioxide, Cutaneous
- BZOSet, Tubing And Support, Ventilator (W Harness)
- FPOStretcher, Wheeled
- FPKTubing, Fluid Delivery
- CBPValve, Non-Rebreathing
- CBKVentilator, Continuous, Facility Use
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1939-2015 | 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. | Class II | Terminated | |
| Z-0816-2012 | 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 Sechrist Monoplace Hyperbaric Chambers. It is not intended for general hospital patient transport and is sold only to be used in conjunction with Sechrist Monoplace Hyperbaric Chambers. | 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 there been reported failure events resulting | Terminated | ||
| Z-0209-2013 | Sechrist Monoplace Hyperbaric Chamber with Electronic Control Module Model 3600E/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. | Class II | Terminated | |
| Z-0208-2013 | 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. | Class II | Terminated | |
| Z-0737-2008 | Sechrist Hyperbaric Chamber Gurney, Standard Gurney Without Siderails & Stretcher Model, P/N 21487, 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) | Terminated | ||
| Z-0736-2008 | Sechrist Hyperbaric Chamber Gurney, Hydraulic Gurney & Standard Stretcher Model, P/N 21466, 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) | Terminated | ||
| Z-0735-2008 | Sechrist Hyperbaric Chamber Gurney, Hydraulic Gurney & Deluxe Wide Stretcher Model, P/N 21465, 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) | Terminated | ||
| Z-0734-2008 | Sechrist Hyperbaric Chamber Gurney, Standard Gurney & Deluxe Wide Stretcher Model, P/N 21464, 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) | Terminated | ||
| Z-0733-2008 | 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) | Terminated | ||
| Z-1032-04 | 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. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain