FLUTTER(R)— 510(k) K946083

Clearance details

Applicant

Bradstreet Clinical Research Assoc., Inc.

Product code

Code BYI

Device class

Class 2

Regulation

21 CFR 868.5665

Advisory panel

Anesthesiology

Date received

1994-12-13

Decision date

1995-03-13

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Brunswick, NJ, US

• K252849 — AffloVest® Mobile Airway Clearance Therapy2026-04-30
• K250860 — BreatheBand® (Model 1000)2025-10-02
• K242063 — LibAirty Airway Clearance System2024-12-19
• K240959 — Respiratory Muscle Trainer2024-12-18
• K233441 — The Vest APX System (PVAPX1)2024-03-22

• K972859 — FLUTTER D1998-06-05
• K951182 — RYDER CONTACT LENS CASE MODEL 106701995-05-16
• K951181 — RYDER CONTACT LENS CASE1995-05-12

Death

3

Total

3

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-1006-2015 — FLUTTER Percussor respiratory device, packaged one unit per clear plastic package. Product Usage: Product is a percussor device, intended to be used as a mucus clearance device for patients with mucus producing respiratory conditions such as: atelectasis, bronchitis, bronchiectasis, cystic fibrous, chronic obstructive pulmonary disease (COPD) and asthma.Class II·Terminated·Aptalis Pharmatech Inc.·20141113

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K946083.