CASSIE— 510(k) K252628
Substantially EquivalentWesper, Inc.
FDA 510(k) clearance K252628 for CASSIE, Substantially Equivalent on 2026-04-27. Applicant: Wesper, Inc.. Device class: 2.
Summary
CASSIE comes from Wesper, Inc. and is filed under product code MNR (Ventilatory Effort Recorder). The record doesn't describe the device beyond its name and that code name.
Class II, 21 CFR 868.2375. Anesthesiology is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Wesper filed from Long Island City, New York. The decision came 250 calendar days after FDA received it (August 20, 2025 to April 27, 2026).
Clearance details
- Applicant
- Wesper, Inc.
- Product code
- Product code MNR
- Device class
- Class 2
- Regulation
- 21 CFR 868.2375
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Long Island City, NY, US
Recent devices under product code MNR
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