Resusci Flow; Resusci Flow 104
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K102542 FDA 510(k)
- FDA Product Code
- BTL FDA 510(k)
- Models / Variants
- Resusci Flow FDA 510(k)Resusci Flow 104 FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 868.5925 FDA 510(k)
- Regulation Number
- 868.5925 FDA 510(k)
- Advisory Committee
- Anesthesiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Resusci Flow is a powered emergency ventilator designed for neonatal and premature infant resuscitation. Classified as a Ventilator, Emergency, Powered (Resuscitator), it delivers controlled artificial respiration with stable pressure to support resuscitation efforts in critical newborn care settings.
This device is intended for single-use in clinical environments and has received FDA 510(k) clearance under the Traditional pathway. It operates via a face mask applied to the infant’s mouth, with inspiratory time controlled by a T Flow Valve. Supplied sterile and regulated under FDA classification II, the Resusci Flow 104 is intended for use in obstetrics and neonatal intensive care units.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Resusci Flow | Product | ATOM MEDICAL, ATOM Medical USA | Resusciflow, PDF Resusci Flow, Resusci Flow Service Manual | PDF | Flow Measurement | Valve
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K102542 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Atom Medical Corporation
Sources (1)
- FDA 510(k) K102542 24 fields · synced Sep 18, 2026