Bottle, Blow
The Bottle, Blow is a simple device used in respiratory therapy in which the patient blows into a bottle containing water to create resistance and encourage deep exhalation and lung re-expansion, often used in post-operative pulmonary rehabilitation. It is classified as FDA Class 1, the lowest risk category, subject to general controls only. The product code is BYO, regulated under 21 CFR 868.5220 in the Anesthesiology specialty. This device is exempt from Good Manufacturing Practice (GMP) requirements.
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Basic Information
- Product Code
- BYO
- Device Class
- FDA class 1
- Regulation Number
- 868.5220
- Medical Specialty
- Anesthesiology
- Review Panel
- AN
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K924541 | EPIDURAL MINIPACK | Jul 09, 1993 | Unknown | Concord/Portex |
| K913527 | HYPERFREE | Jan 21, 1992 | Substantially Equivalent | Kist Intl. |
| K780558 | BOTTLE BREATHING DEVICE | May 26, 1978 | Substantially Equivalent | B & F Medical Products, Inc. |
| K780407 | 2C7125 BLOW BOTTLE | Apr 10, 1978 | Substantially Equivalent | Travenol Laboratories, S.A. |
FEI Numbers
This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.