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Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Sechrist Industries, Inc. — Predicate Candidate Screening

23 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

71 daysmedian FDA review time
217 days90th percentile
23clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K140559SECHRIST MONOPLACE HYPERBARIC OXYGEN CHAMBERSechrist Industries, Inc.2014-05-30860
K100268SECHRIST MONOPLACE HYPERBARIC OXYGEN CHAMBERSechrist Industries, Inc.2010-04-26870
K052713MODEL 3300E/ER MONOPLACE HYPERBARIC OXYGEN CHAMBERSechrist Industries, Inc.2005-10-28292
K023745SECHRIST AIR/OXYGEN MIXER, MODEL 3500 CP-GSechrist Industries, Inc.2003-01-17710
K993167MILLENNIUM INFANT VENTILATORSechrist Industries, Inc.1999-11-10490
K992503SECHRIST AIR-OXYGEN MIXER, 3500/3500HL SERIESSechrist Industries, Inc.1999-08-10140
K950386MODEL 3200P/3200PR HYPERBARIC CHAMBERSechrist Industries, Inc.1995-06-131320
K934164MODEL 2500E/2500ER HYPERBARIC CHAMBERSechrist Industries, Inc.1995-06-136550
K930713THE INFANT FLOW SYSTEMSechrist Industries, Inc.1993-09-162170
K914607SEHRIST VOLUME VENTILATOR, MODEL 2200BSechrist Industries, Inc.1992-11-023820
K896269SECHRIST VOLUME VENTILATOR MODEL 2200BSechrist Industries, Inc.1990-05-181990
K895853SECHRIST DISPOSABLE INFANT BREATHING CIRCUITSechrist Industries, Inc.1989-12-22800
K884543LSP DEMAND INHALATOR VALVE MODEL SPOO68 W/MASKSechrist Industries, Inc.1988-12-13430
K884156HYPERBARIC INTRAVENOUS INFUSION EXTENSION SETSechrist Industries, Inc.1988-11-14410
K861330SECHRIST AIRWAY PRESSURE MONITOR MODEL 600Sechrist Industries, Inc.1986-04-1120
K850740SECHRIST VOLUME VENTILATOR MODIFICATIONSechrist Industries, Inc.1985-07-291820
K833982MODEL IV 100B-DA INFANT VENTILATORSechrist Industries, Inc.1984-03-051091
K832508VOLUME VENTILATORSechrist Industries, Inc.1983-12-271530
K821930SECHRIST MODEL 990 JET VENTILATORSechrist Industries, Inc.1982-08-16480
K811141SECHRIST INFANT VENTRILATOR MODEL IV-100Sechrist Industries, Inc.1981-06-12461
K810648SECHRIST AIRWAY PRESSURE MONITOR #400Sechrist Industries, Inc.1981-03-2090
K802226SECHRIST SERIES 3500 AIR-OXYGEN MIXERSechrist Industries, Inc.1980-09-26140
K780188INFANT VENTILATOR MODEL 100Sechrist Industries, Inc.1978-04-10630

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda