FDA product code BYO: Bottle, Blow
BYO is the FDA product code for bottle, blow. It is a Class I device, regulated under 21 CFR 868.5220 and reviewed by the Anesthesiology panel. FDA has cleared 4 510(k) submissions under BYO, from 4 different applicants. The average 510(k) review took 137 days (median 108).
Classification
| Field | Value |
|---|---|
| Device name | Bottle, Blow |
| Device class | Class I |
| Regulation | 21 CFR 868.5220 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every BYO clearance
Top BYO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Concord/Portex | 1 | 1993-07-09 |
| Kist Intl. | 1 | 1992-01-21 |
| B & F Medical Products, Inc. | 1 | 1978-05-26 |
| Travenol Laboratories, S.A. | 1 | 1978-04-10 |
Most recent BYO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K924541 | Concord/Portex | EPIDURAL MINIPACK | 1993-07-09 | 304 |
| K913527 | Kist Intl. | HYPERFREE | 1992-01-21 | 166 |
| K780558 | B & F Medical Products, Inc. | BOTTLE BREATHING DEVICE | 1978-05-26 | 51 |
| K780407 | Travenol Laboratories, S.A. | 2C7125 BLOW BOTTLE | 1978-04-10 | 28 |
Recalls for BYO devices
openFDA lists no recalls for product code BYO.
Frequently asked questions
What is FDA product code BYO?
BYO is the FDA product code for bottle, blow. It is a Class I device, regulated under 21 CFR 868.5220 and reviewed by the Anesthesiology panel.
What device class is BYO?
Class I, regulation 21 CFR 868.5220. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code BYO?
Across 4 cleared submissions the average was 137 days from receipt to decision (median 108).
Which companies have the most BYO clearances?
Concord/Portex (1); Kist Intl. (1); B & F Medical Products, Inc. (1); Travenol Laboratories, S.A. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code BYO
- Run a recall and safety report across every BYO manufacturer
- Watch product code BYO for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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