REMSTAR AUTO A-FLEX— 510(k) K091319

Clearance details

Applicant

Respironics Inc., Sleep & Home Respiratory Group

Product code

Code BZD

Device class

Class 2

Regulation

21 CFR 868.5905

Advisory panel

Anesthesiology

Date received

2009-05-05

Decision date

2009-08-03

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Murrysville, PA, US

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• K092835 — COMFORTGEL NASAL MASK2010-02-12
• K092648 — RESPIRONICS PERFORMAX SE TOTAL FACE MASK2009-12-18
• K090539 — BIPAP AUTOSV ADVANCED2009-10-30
• K091191 — GAS TRANSFILL2009-10-23
• K091843 — COMFORT TWIN NASAL MASK2009-09-10

Death

4,440

Injury

53,099

Malfunction

213,222

Other

17

Total

270,778

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-1974-2021 — SystemOne (Q-Series), DreamStation, DreamStation Go, Dorma 400, Dorma 500, REMstar SE Auto Noncontinuous Ventilators The Philips Respironics E30 ventilator is intended to provide invasive and non-invasive ventilatory support for individuals with Respiratory Insufficiency. It is specifically for the care of adult and pediatric patients >7 years of age and >18kgs.Class I·Ongoing·Philips Respironics, Inc.·20210614

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K091319.