KENDALL SHERIDAN CPAP SYSTEM— 510(k) K953511

Clearance details

Applicant

Kendall Healthcare Products Co. Div.Of Tyco Health

Product code

Code BYE

Device class

Class 2

Regulation

21 CFR 868.5965

Advisory panel

Anesthesiology

Date received

1995-07-26

Decision date

1995-10-26

Decision

Unknown

Clearance type

Traditional

Location

Mansfield, MA, US

• K160112 — Besmed PEEP Valve2016-04-29
• K133957 — DISPOSABLE ADJUSTABLE PEEP VALVE MR CONDITIONAL USE2014-04-14
• K133210 — B&B BUBBLER2014-03-28
• K122610 — PLAXTRON CPAP SYSTEM, MODEL CH-FFM-87XX/CH-FFM-88XX SERIES2013-08-05
• K112546 — O_TWO CPAP SYSTEM2011-12-27

• K973763 — KENDALL CURITY IODOFORM PACKING STRIP1997-12-31
• K973511 — KENDALL CURITY PETROLATUM GAUZE1997-12-16
• K973507 — KENDALL XEROFORM PETROLATUM DRESSING (6311,6312,6313,6314,6315,6316,6317)1997-12-15
• K973619 — KENDALL CURITY NON-ADHERING DRESSING1997-12-10
• K973509 — KENDALL CURASORB ZN + MG ALGINATE WOUND DRESSING1997-12-04

Death

5

Total

5

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 →