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

Devilbiss Health Care, Inc. · Predicate Candidate Screening

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

155 daysmedian FDA review time
332 days90th percentile
29clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K963349DEVILBISS 8650DDevilbiss Health Care, Inc.1997-06-132910
K970289COMPRESSOR/NEBULIZER #3650Devilbiss Health Care, Inc.1997-04-15810
K961126PULSE DOSE SERIESDevilbiss Health Care, Inc.1996-10-212140
K950849MODEL #7354Devilbiss Health Care, Inc.1996-02-083490
K952491MODEL 7355Devilbiss Health Care, Inc.1996-01-312460
K952249JET NEBULIZERDevilbiss Health Care, Inc.1996-01-302600
K9538155 LPM OXYGEN CONCENTRATORDevilbiss Health Care, Inc.1995-11-09870
K9520373 LPM OXYGEN CONCENTRATORDevilbiss Health Care, Inc.1995-09-061280
K946095DEVILBISS MODEL 5500Devilbiss Health Care, Inc.1995-08-242530
K944611MODEL# 7500 SURVEYORDevilbiss Health Care, Inc.1995-04-212140
K935979CONTINUOUS POSITIVE AIRWAY PRESSURE CPAP SYSTEMDevilbiss Health Care, Inc.1994-11-103320
K931015DEVILBISS MODEL 4650 COMPRESSOR NEUBULIZERDevilbiss Health Care, Inc.1993-09-302160
K924152KEYSTONE CONCENTRATOR, MODEL PV5LDevilbiss Health Care, Inc.1993-06-072930
K923888DEVILBISS MODEL 5650 PULMO-AIDEDevilbiss Health Care, Inc.1993-02-232030
K921499SEAL RING FOR NASAL CPAPDevilbiss Health Care, Inc.1992-09-171700
K913392OXYGEN SENSING DEVICE, MODIFICATIONDevilbiss Health Care, Inc.1992-07-173540
K913316DEVILBISS MODEL 7427DDevilbiss Health Care, Inc.1991-12-111400
K911896DEVILBISS MODEL 5000Devilbiss Health Care, Inc.1991-07-31960
K904344SLEEPER MASK SYSTEMDevilbiss Health Care, Inc.1991-05-012190
K904766DEVILBISS MODEL 7352 SERIESDevilbiss Health Care, Inc.1991-03-261550
K900602DEVILBISS AP-50 COMPRESSOR/NEBULIZERDevilbiss Health Care, Inc.1990-04-23740
K896457DEVILBISS MODEL PV02 SERIESDevilbiss Health Care, Inc.1990-02-01800
K896090DEVILBISS MODEL 6300DDevilbiss Health Care, Inc.1989-11-30420
K894441DEVILBISS MODEL 6610DDevilbiss Health Care, Inc.1989-10-13880
K894244DEVILBISS MODEL 8500D AND 8500D-608Devilbiss Health Care, Inc.1989-10-061070
K894424DEVILBISS MODEL 7351 SERIESDevilbiss Health Care, Inc.1989-09-18630
K894690CPAP MASKDevilbiss Health Care, Inc.1989-09-08460
K893388DEVILBISS MODEL 7351D REVITALIZER CPAP SYSTEMDevilbiss Health Care, Inc.1989-06-23530
K890141DEVILBISS MODEL 1400D (OXYGEN CONSERVING DEVICE)Devilbiss Health Care, Inc.1989-04-06830

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